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

Model Number	GELSOFT PLUS BIFURCATE
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - no information received on patient.(b)(4).Historical data analysis: review of similar events related to gelsoft plus bifurcate manufactured using gelita gelatin.Review of batch qc and manufacturing records was carried out.Device not accessible for testing.Device remains implanted in patient and will not be returned for analysis no device problem found.Qc, manufacturing and physical test records were retrieved and reviewed and show batch was manufactured to specification.A 5-year similar event review for gelsoft plus gelita leakage events gave an occurrence rate of (b)(4).(complaints v sales).There was no indication of an increasing trend.Vascutek ltd.Requested further information from site however we have been informed that no further information will be received.Cause not established.No root cause could be established from review of production records or information received, 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
Terumo (b)(4) was informed by (b)(6) on 28-jul-20 of an event which occurred in (b)(6) on (b)(6) 2020 as follows: after implantation, the or team noted after declamping 2 holes at the bifurcation level.The team clamped and sewed the holes with a continuous suture between aorta and prosthesis.No further treatment was administered to the patient.The procedure was delayed by approximately 10 minutes.

• 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: 10447040
• Report Number: 9612515-2020-00008
• Device Sequence Number: 14333809
• Product Code: DSY
• UDI-Device Identifier: 05037881115511
• UDI-Public: 05037881115511
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K162803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2020
• Report Date (Section F): 07/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 631407P-G
• Device Lot Number: 17711887
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2020
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/25/2020
• 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