MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT PLUS; GELSOFT PLUS GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS

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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No known impact or consequence to patient: no reported significant delay to procedure, patient consequence or harm.Bleeding was halted with application of suture and patient reported as stable post op.(b)(4).Historical data analysis: a 5-year review of previous gelsoft plus complaints was carried out and gave an occurrence rate of 0.010%.Analysis of production records: review of retained qc, manufacturing and physical testing records performed: a review of retained qc and manufacturing records showed that this batch was manufactured to specification with no issues raised.A review of the graft base material physical tests showed all testing met acceptance criteria.Base material porosity tests and finished product porosity tests were all within specification with no issues highlighted.Device not accessible for testing: device remains implanted in patient and will not be returned for testing.No device problem found: review of product batch records showed no issue with the manufacture of this batch.Cause not established - cause of the leakage could not be established from review of qc and manufacturing records: response to question from site did not indicate any deviation from ifu recommendations or mishandling of product.Vascutek ltd.Is submitting this report as an initial/final report.No further information available and no investigation is possible as device remains implanted.Vascutek ltd.Now considers this complaint closed 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
Event was reported to vascutek ltd.As follows: after the implant was anastomosed (proximal), the surgeon noticed one (1) hole in the graft (at the bifurcation level).The surgeon decided to keep the graft in place and suture the hole.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8797150
• Report Number: 9612515-2019-00019
• Device Sequence Number: 11398122
• Product Code: DSY
• UDI-Device Identifier: 05037881115528
• UDI-Public: 05037881115528
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2019
• Report Date (Section F): 06/19/2019

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: 02/28/2022
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 631608P-G
• Device Lot Number: 17602557
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/19/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/17/2019
• 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