MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE GELATIN IMPREGNATED WOVEN VASCULAR PROSTHESIS

Model Number GELWEAVE STRAIGHT

Device Problems Leak/Splash (1354); Use of Device Problem (1670); Material Integrity Problem (2978); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information was received.Device returned on 04-sep-2017; however, evaluation not complete at time of this report submission.(b)(4) - no known impact or consequences to patient - reported as no serious injury to patient.(b)(4) - material integrity issue - it was reported that blood leaked from the surface of the graft.(b)(4) - leak - it was reported that blood leaked from the surface of the graft.(b)(4) - use of device issue - the device was used for blood transmission during cardio pulmonary bypass.Gelweave straight grafts are designed for 'systemic vascular repair' procedures and the method of use as defined by the reporter - cardio pulmonary bypass - is not indicated within the ifu, thus its use was off-label (b)(4) - device handling issue - the clinician in attendance reported that the graft had been clamped with forceps and also may have rubbed against the edge of the connector to bypass equipment possibly leading to damage of the gelatin coating.It was not indicated if the forceps used were atraumatic forceps with soft shod jaws as recommended in ifu.Method - process evaluation - a complete review of the manufacturing and qc records was carried out.No issues were identified with the manufacture of the device.Method - manufacturing review - a complete review of the manufacturing and qc records was carried out.No issues were identified with the manufacture of the device.Method - sterilisation review - a review of sterilisation records was carried out and confirmed that all acceptance criteria were met for sterilisation cycle.Result - no failure detected - no issue with the device manufacture or processing could be identified from review of manufacturing qc and sterilisation records.Conclusion - conclusion not yet available - investigation of returned device sample is ongoing and is not yet complete at time of this report submission.Conclusion - off-label, unapproved or contraindicated for use.- as indicated above, gelweave grafts are designed for 'systemic vascular repair' procedures and the method of use as defined by the reporter - cardio pulmonary bypass - is not indicated within the ifu, thus its use was off-label.A sample of the graft has been returned and will be investigated for completeness of investigation of this event and findings will be reported in next follow up/final report.

Event Description

The event was reported to vascutek on 14th august as follows; after a straight connector for artificial cardio pulmonary bypass was inserted into the graft for blood transmission during ascending aorta replacement surgery and blood flow was commenced, leakage was identified in part of the graft body.Additional information received on 16th august; vascutek was informed that intervention by use of haemostatic agent (hydrofit) was required to stop leakage and that the graft had not been pre-soaked in saline prior to use as recommended in ifu.

Manufacturer Narrative

Actual device evaluated - a 53mm unused section of the graft was returned for evaluation.Flow testing - sample was subjected to permeability testing with water as per base material routine in process testing at 16kpa.Visual inspection - returned sample was visually inspected for any flaws, holes or soiling.Microscopic inspection - fabric analysis was carried out under magnification by textile department to ensure correct amount of fabric ends and picks per cm were present in weave.No failure detected - all testing met acceptance criteria and no anomalies or defects were detected on the retuned sample.Unable to confirm complaint - vascutek was unable to confirm complaint through testing, visual inspection or review of qc and manufacturing records.Vascutek's investigation found the following: the review of manufacturing records and qc test results showed that the batch was manufactured to specification.The whole graft porosity results for the batch were well below the maximum limit.A 5-year review of similar complaints (woven polyester graft leakages) gave a low occurrence rate of 0.02%.Leakage is covered within the products risk documentation.Testing of returned sample did not detect any flaws in the fabric.Vascutek has received one other complaint related to a graft from this batch (vak ref comp3477).This complaint also involved the use of the graft for cardio pulmonary bypass.The complaint graft was not returned for this additional complaint and therefore the sample returned for this one was used as a basis for the report on this event mfr report #: 9612515-2017-00017 which is due to be submitted on (b)(6) 2017.As indicated in initial report for this event the device was used off label and investigation of the returned sample did not detect any issue with the graft structure, 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.(b)(4).

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE GELATIN IMPREGNATED WOVEN VASCULAR PROSTHESIS
• 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: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 6854445
• MDR Text Key: 85613569
• Report Number: 9612515-2017-00015
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881105079
• UDI-Public: 05037881105079
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K952293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2017,10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 731508
• Device Lot Number: 16159870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/02/2017
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2017
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• 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