MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE EXTRA LONG BIFURCATE

Model Number	GELWEAVE
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	03/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On the (b)(6) 2020 vascutek ltd.Received the following information from our distributor ((b)(6): a patient underwent an aorto bi-femoral bypass procedure and a gelweave extra long bifurcate device was used.The patient suffered immediate thrombosis.Intervention was performed (unknown type).The patient was later transferred to intensive care.
Additional Manufacturer Narrative
Manufacturers narrative: section h6 conclusion code - 67 - no problem found - as no device or diagnostic scan data was returned and no issues found with regards to the analysis of production records, no root cause has been determined.Vascutek ltd.Now considers this complaint closed.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 develop, action may be taken at that time.
Event or Problem Description
Original information received: on the 26-mar-20 vascutek ltd.Received the following information from our distributor (terumo france): the event was reported as follows: a patient underwent an aorto bi-femoral bypass procedure and a gelweave extra long bifurcate device was used.The patient suffered immediate thrombosis.Intervention was performed (unknown type).The patient was later transferred to intensive care.Additional information received: following the procedure, and during the night the patient presented with an incomplete acute ischemia of the right lower limb.Doppler imaging confirmed an occlusion in the right leg.Intervention performed.Surgical approach made at the level of the right scarpa.The fogarty brings back a significant quantity of fresh thrombus.Arteriography shows thrombus within the body of the prosthesis and in the left leg.The laparotomy is redone as well as the left scarpa.Aortic clamping, upon opening of the aortic anastomosis; the body of the prosthesis is the seat of an adherent thrombus which is removed with forceps.Fogarty complementary in the 2 legs and the deep femorals.Closure of the surgical access was completed.Favorable evolution then and doppler control finding no residual thrombus and a normal permeability of the prosthesis.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE EXTRA LONG BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 9985167
• Report Number: 9612515-2020-00003
• Device Sequence Number: 14573416
• Product Code: DSY
• UDI-Device Identifier: 05037881107639
• UDI-Public: 05037881107639
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020
• Report Date (Section F): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: GELWEAVE
• Device Catalogue Number: 731608XL55
• Device Lot Number: 17851676 - 2384
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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: Required Intervention
• Patient Age: 74 YR