MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE VALSALVA ANTE-FLO

Model Number GELWEAVE

Device Problem Hole In Material (1293)

Patient Problem Aneurysm (1708)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: actual device is not being returned.Method: process evaluation carried out, retained device qc and manufacturing history records reviewed.Results: no failure detected, review of records show batch was manufactured to specification.Conclusion: unable to confirm complaint.Conclusion: device not returned.There was no returned sample for this event and no grafts still available from the batch as the device was manufactured in 2008.Any remaining product from this batch will have been used or will have expired.This 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 now considers this complaint as closed.

Event Description

The event was reported to vascutek as follows; the valsalva implanted in the patient 7 years ago leaked blood, where a false aneurysm formed and re-operation was required.Leaks were noted at two points on the reference line on the skirt which is the segment that has contact with the pulmonary vein.The graft in question was not changed out.Instead some stitches were added and the bleeding stopped.Bleeding was also noted at the anastomosis with the coronary artery.

Manufacturer Narrative

Additional manufacturer narrative: an initial /final report for this event was submitted on 30th september 2015.However on the 7th october 2015 vascutek received a cd containing video files of the procedure.Vascutek clinical services manager reviewed this cd and has advised that there is disease progression but not necessarily relating to the leak in the graft.The leaks could actually be caused by the new sutures as a cutting needle is being used throughout.From the video images received it could be seen that there was some minor bleeding /blushing of the graft but it could not be determined if this was the cause of the false aneurysm.However when suturing the graft, it can be clearly seen that cutting needles were used.This is contrary to ifu recommendations that only round body tapered needles should be used to minimise fibre damage.At this point there is a noticeable increase in blood leakage.Due to oversight vascutek did not submit a further report at the time additional information became available.Conclusion: unable to confirm complaint - review of video images received could not determine a definitive root cause for the aneurysm or bleeding reported; device not returned - without the return of the device vascutek could not investigate further to determine a definitive root cause for the aneurysm or bleeding reported; user error caused or contributed to the event.- the use of cutting needles cause or contributed to the bleeding reported to vascutek.This 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 now considers this complaint as closed.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE VALSALVA ANTE-FLO
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9-RR ; UK PA4 9RR ; 1418125555
• MDR Report Key: 5113709
• MDR Text Key: 27103830
• Report Number: 9612515-2015-00026
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/01/2015,10/14/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: GELWEAVE
• Device Catalogue Number: 734028/10ADP
• Device Lot Number: 85370 0667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/24/2015
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2008
• 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