MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS; GELSOFT PLUS BIFURCATE

Catalog Number	632520P-G
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of manufacturing and qc records confirmed that the device was manufactured to specification.Without the return of the graft for analysis vascutek ltd are unable to determine a root cause for this event.However from a review of clinical papers and the device ifu it has been noted that dilatation is a known and expected complication of this type of procedure due to the knitted structure of the graft.The percentage of dilatation varies significantly throughout literature.In the last five years from 2014 to 2019 vascutek ltd has received a total of 8 complaints, for knitted grafts where dilatation of the graft has been reported as an issue.Sales for this period and graft type is (b)(4) units.This gives a very low incident rate of (b)(4).As dilatation of knitted grafts is inherent and expected there is no common industry incident rate for comparison.On this basis vascutek now considers this complaint closed.However this issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops actions will be taken at that time.
Event or Problem Description
The event, which occurred in (b)(6) was reported to vascutek ltd as follows: the patient received bifurcated graft.During ct follow up the physician observed an increase of the diameter of the main graft body to 29.8-31mm.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8734291
• Report Number: 9612515-2019-00011
• Device Sequence Number: 2637266
• Product Code: DSY
• UDI-Device Identifier: 05037881115283
• UDI-Public: 05037881115283
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2019
• Report Date (Section F): 05/29/2019

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: 08/31/2021
• Device Catalogue Number: 632520P-G
• Device Lot Number: 17483567 1479
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1