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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 025 01 13 000
Date submitted: 1/13/2013
Manufacturer:Vascutek Limited
Device Type:Vascular Grafts, Biplex vascular grafts and Biplex BioValsalva conduits
Synthetic vascular graft and cardiac valve graft/vascular prosthesis, animal derived
Medical Device Identifier: Catalogue Numbers: Biplex straight vascular grafts BL6006, BL6007,BL6008, BL6009, BL6010, BL6011, BL6012. BL6014.BL6016,BL4006, BL4008, BL3006, BL3007, BL3008, BL3009, BL3010, BL3011, BL3012, BL3014. 8L3016, Bl1506, BL1507, BL1508, BL1509, BL1510, BL1511, BL1512, BL1514, BL1516, BL5016.BL5018,BL5020j BL5022, BL5024, BL5026, Bl5028, BL5030, BL5032, BL5034, BL5036, BL5038, BL0526. BL0528, BL2518, BL2520, BL2522, BL2524, BL2526, BL2528, BL1218, BL1220, BL1222, BL1224, BL1226, BL1228. BL3018, BL3020, BL3022, BL3024, BL3026, BL3028, BL3030, BL3032, BL3034, BL3036, BL3038, BL1030, BL1032, BL1034, BL1036, Bl2030, BL2032, BL2034, BL2036, BL2038, BL4030, BL4032 Bt4034. BL4036, BL4038, BL6018, BL6020, BL6022, BL6024, BL6026, BL6028, BL6030, BL6032,BL6034. BL6036,BL6038 Biplex Valsalva vascular grafts BL0022ADP, BL0024ADP, BL0026ADP, BLO028ADP, BL0030ADP, BL0032ADP, Bl0034ADP Biplex Biovalsalva Conduit (stentless) EHVC21, EHVC23, EHVC25. EHVC27 . Stented Biovalsalva ~()nduit (Biplex stQl"ited) AHVC25, AHVC27, AHVC29 Batch No: All batches Serial No: All serial numbers
Reason of Field Safety Corrective Action: Vascutek has received a number of events involving graft bleeding including anastomotic bleeding and suture hole bleeding, either during or shortly after surgery.
Remedy Action: To reduce the risk of bleeding, Vascutek advise that clinicians are aware of an additional 5 cautions relating to sizing and insertion instructions: 1. It is essential that the sutures are tightened each time they are passed through the material. 2. In order to achieve a smooth suture line and good haemostasis, it is important that the graft diameter selected must not be oversized relative to the distal anastomotic site. 3. Care should be taken not to apply excessive tension at the distal anastomosis by ensuring the graft is cut to the correct length. 4. The use of haemostatic agents / accelerants and/or felt/ pledgets may reduce the incidence of suture line bleeding and restemotomy. 5. The use of an oblique / bevel graft to vessel anastomosis is recommended. This technique will minimize any blood leakage arising from the oversizing of the graft relative to the native vessel.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:UK-2013-01-07-004
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Vascutek Limited.pdf