MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE 4 BRANCH PLEXUS

Model Number	73221088/10SA
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method - device not evaluated - device remains implanted within the patient therefore not available for evaluation.Process evaluation - a review of manufacturing and qc process was carried out.Manufacturing review - a review of manufacturing and qc process was carried out.Sterilisation process review - a review of sterilisation records for this device was carried out.Photographic inspection - a review of images of the procedure was carried out.Results - no result available - device remains implanted within the patient therefore not available for evaluation.No failure detected - a complete review of the manufacturing, qc and sterilisation records did not identify any issues with the manufacture of the device.Conclusion - device not returned - device remains implanted within the patient therefore not available for evaluation.Unable to confirm complaint - a complete review of the manufacturing, qc and sterilisation records did not identify any issues with the manufacture of the device.Use error caused or contributed to the event - clinical review of the images observed that uncovered clamps were used during procedure which could have damaged the graft.As per ifu for polyester devices "clamping may damage any vascular prosthesis.Atraumatic clamps, ideally with soft shod jaws, should be used with a minimum application of force." a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.No issues identified with batch manufacture of physical testing of base material.No issues found with porosity testing or results.A 5-year review of similar events gave an occurrence rate of (b)(4) (complaints v sales).There have been no similar complaints received from the other units of the same batch.A review of ncrs for the past 5 years did not identify any negative trends.No ncrs were raised in relation to the complaint item.There are no related capas for this issue.Sterilisation records were reviewed which confirmed that there were no issues with sterilisation process.As a complaint device was not available no further investigation can be carried out.Vascutek now consider this event closed; however, the event type will continue to be tracked and trended through the complaint's monitoring system.If a negative trend arises corrective actions may be considered at the time.Device was not returned for evaluation.
Event or Problem Description
Vascutek have received notification of the event that was described as leakage at the base of the branch area.To stop the leak, clinician patched the affected area with a felt piece and the leak was successfully stopped.Note: the actual complaint device is not approved for sale in the usa; however, similar devices are; therefore, vascutek is reporting this event.

• Brand Name: GELWEAVE 4 BRANCH PLEXUS
• Common Device Name: GELWEAVE 4 BRANCH PLEXUS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 6551101
• Report Number: 9612515-2017-00006
• Device Sequence Number: 225847
• Product Code: DSY
• UDI-Device Identifier: 05037881998473
• UDI-Public: 05037881998473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040829
• 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): 05/08/2017
• Report Date (Section F): 04/10/2017

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: 04/30/2021
• Device Model Number: 73221088/10SA
• Device Catalogue Number: 73221088/10SA
• Device Lot Number: 384034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 05/08/2017
• 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