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

Model Number	GELSSOFT PLUS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/12/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device being returned but not yet received at vascutek.(b)(4).Method - actual device not evaluated - evaluation of device expected however device not received at this time; process evaluation - carried out review of manufacturing process for batch; manufacturing review - review of dhr and physical testing records.Sterilisation process review - carried out review of sterilisation process records.Results - no failure detected - no issue found with review of manufacturing, physical testing or sterilisation of batch.Results pending completion of evaluation of returned device - awaiting return of device to carry out evaluation.Conclusion - conclusion not yet available- evaluations continuing.
Event or Problem Description
Reported to vascutek as: while suturing graft at implant, dr.Found blood leakage from a hole in graft.Hole was repaired with suture however dr.Then decided to explant graft and replace with new one.No clamps were used during procedure and graft pre-soaked as per ifu indications.Blood loss reported as minimal at less than 2cc.Explanted graft to be returned for investigation.
Additional Manufacturer Narrative
Additional manufacturers narrative method code: actual device evaluated- complaint graft was returned in 2 sections for investigation.Flow testing - graft was tested for porosity with water as per routine in-process testing of base fabric.Visual inspection - graft was visually inspected before and after decontamination.Photographic inspection - graft was imaged using digital camera, digital microscope and under scanning electron microscope (sem).Microscopic inspection - graft was examined under digital microscope.Electron microscopy - graft was inspected and imaged under scanning electron microscope(sem) result code: no failure detected - no failure of the graft was detected under any of the investigation techniques used.Visual inspection of the returned graft did not show any faults, imperfections or holes as reported.Porosity with water test results were within acceptance criteria for base fabric.Inspection of reported area of hole under microscope and sem did not reveal any faults, holes or imperfections on the fabric that could have led to reported leakage.Textile analysis of fabric also showed a sound basic structure of the graft without faults or imperfections.No review or inspection of glycerol/gelatin coating could be undertaken as graft was returned immersed in fluid and all glycerol/gelatin coating had hydrolysed.Conclusion code: unable to confirm complaint - investigation carried out at vascutek could not detect any hole or damage to graft structure that could have led to the reported bleeding.Vascutek now considers this complaint closed, 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.

• 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, scotland PA4 9 RR; UK PA4 9RR
• MDR Report Key: 6046495
• Report Number: 9612515-2016-00026
• Device Sequence Number: 16251818
• Product Code: DSY
• UDI-Device Identifier: 05037881115207
• UDI-Public: 05037881115207
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2016
• Report Date (Section F): 09/21/2016

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: Physician
• Device Expiration Date: 02/28/2021
• Device Model Number: GELSSOFT PLUS
• Device Catalogue Number: 633006P
• Device Lot Number: 376009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Distributor Facility Aware Date: 09/12/2016
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2016
• Supplement Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR