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

Model Number	GELSOFT PLUS BIFURCATE
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: actual device not evaluated - the device was not returned to vascutek as it remains implanted within the patient.No testing method performed - device remained in situ, therefore no further testing occurred.Manufacturing review - a complete review of the manufacturing and qc records was carried out.No issues were identified with the manufacture of the device.Sterilisation review - a review of the sterilisation records was carried out and this confirmed that all acceptance criteria were met for sterilisation.Results: no failure detected - no issues with the device could be identified from the investigation carried out by vascutek.No results available since no device returned - without the return of the device it is not possible to identify a root cause of this event.Conclusion: unable to confirm complaint - no issue with the device could be identified from the investigation carried out by vascutek.Device not returned - without the return of the device it is not possible to identify the root cause of this event.An investigation was completed which showed no issues or adverse trends.A review of manufacturing and qc records confirmed that the device was manufactured to the required specification.Porosity test results for the whole batch of 7 were well below the maximum porosity limit of 77 ml/min.A 5-year review of similar complaints that covered all knitted grafts gave a low occurrence rate of (b)(4) (complaints v sales).There have been no similar complaints from other units of the same batch (7 units in batch).As the device remains in situ within the patient a physical analysis is not possible.The root cause of the event was not identified.Further action is not planned; however, the issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops action may be taken at that time.Vascutek consider this case closed.
Event or Problem Description
The event was reported as leaking prosthesis from several small holes in the material around the bifurcation area.Leaking was not in the area of the suture holes but from spots, that had not been near any needle stick.Tachosil was used to stop the bleeding.

• 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: 7013961
• Report Number: 9612515-2017-00021
• Device Sequence Number: 800005
• Product Code: DSY
• UDI-Device Identifier: 05037881115528
• UDI-Public: 05037881115528
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2017
• Report Date (Section F): 10/12/2017

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: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 631608P
• Device Lot Number: 16318036-0266
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2017
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/09/2017
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 68