MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE GELATIN IMPREGNATED WOVEN VACULAR PROSTHESIS

Model Number	GELWEAVE STRAIGHT
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information was received.Although the actual device for this complaint was not returned a section of device from same lot/batch was returned and investigated in relation to mfr report # 9612515-2017-00015 vak ref:comp 3466 which was previously submitted on 02-oct -17.(b)(4).Gelweave straight grafts are designed for 'systemic vascular repair' procedures and the method of use as defined by the reporter - cardio pulmonary bypass - is not indicated within the ifu, thus its use was off-label as indicated above, gelweave grafts are designed for 'systemic vascular repair' procedures and the method of use as defined by the reporter - cardio pulmonary bypass - is not indicated within the ifu, thus its use was off-label.Vascutek's investigation found the following: the review of manufacturing records and qc test results showed that the batch was manufactured to specification.The whole graft porosity results for the batch were well below the maximum limit.A 5-year review of similar complaints (woven polyester graft leakages) gave a low occurrence rate of 0.02%.Leakage is covered within the products risk documentation.Testing of returned sample did not detect any flaws in the fabric.Vascutek has received one other complaint related to a graft from this batch (vak ref comp3466).Mfr report # 9612515-2017-0015.This complaint also involved the use of the graft for cardio pulmonary bypass.The complaint graft was not returned for this complaint and therefore the sample returned for comp 3466 was used as a basis for the investigation report on this event as indicated, the device was used off label and investigation of the returned sample did not detect any issue with the graft structure.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.
Event or Problem Description
Initial information on event received at vascutek on 07-sep-17 simply stated: leak from fabric.Further information was received on 13-sep-17 stating blood leakage from the body of the graft, the gelweave graft was used for blood transmission.After grafts were anastomosed end-to-end, when blood flow was passed through, unusual large amounts of blood leakage was identified from the graft body and the blood accumulated in the operative field.Although the leaking did not stop, the procedure was continued and successfully completed, after the graft was taken out and the vessel was ligated.No serious injury to patient.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE GELATIN IMPREGNATED WOVEN VACULAR PROSTHESIS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 6916593
• Report Number: 9612515-2017-00017
• Device Sequence Number: 482858
• Product Code: DSY
• UDI-Device Identifier: 05037881105079
• UDI-Public: 05037881105079
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2017
• Report Date (Section F): 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 731508
• Device Lot Number: 16159870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/01/2017
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other