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

Model Number GELSOFT PLUS BIFURCATE

Device Problems Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 07/02/2020

Event Type  malfunction  

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 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
• Type of Device: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 10447040
• MDR Text Key: 205155450
• Report Number: 9612515-2020-00008
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115511
• UDI-Public: 05037881115511
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K162803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2020,08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• 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
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention