MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE PLEXUS

Model Number GELWEAVE PLEXUS

Device Problem Material Twisted/Bent (2981)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

Clinical code: 4581-appropriate clinical signs, symptoms, conditions term / code not available - reported as graft was bent - the patient has not recovered.Damage the patients health is serious.Impact code: 4633-surgical procedure delayed - tevar was aborted, tevar will be performed at a later date.4625-additional surgery - thoracotomy is planned to place an open sten graft in the graft concerned to correct the bending.Medical device problem: 2981-material twisted/bent - graft was reported as bent.Component code: 4755-part/component/sub-assembly term not applicable: type of investigation: 4114-device not returned: device remains implanted 4110-trend analysis: a 5-year review of similar complaints (appearance>>product defect>>curled/kinked/folds/twisted) gave an occurrence rate of (b)(4) (complaints v sales).4111 - communications/interviews - additional information has been requested from the site, include device details.

Event Description

Graft was bent: on (b)(6), 2023, elephant trunk was performed and the graft concerned was implanted.On (b)(6), 2023, when performing second-stage tevar, angiography revealed that the graft was bent in the vessel.A guidewire was passed through the graft and tension was applied to the guidewire in an attempt to straighten the graft using the pull-through technique.However, bending of the graft was unable to be corrected.Therefore, tevar was aborted and the procedure was terminated.Thoracotomy is planned to place an open stent graft in the graft concerned to correct bending.Tevar will be performed at a later date.The physician is concerned about the strain on the patient's body as the patient will have to undergo thoracotomy again.Operation type: tevar as a second-stage procedure.Blood loss: unknown.

Event Description

This report is being submitted as a follow up #1 foro manufacturing report #9612515-2023-00036 to provide event closure information for (b)(4).

Manufacturer Narrative

Manufacturers narrative clinical code 4581-appropriate clinical signs, symptoms, conditions term / code not available - reported as graft was bent - the patient has not recovered.Damage the patients health is serious.Impact code 4633-surgical procedure delayed - tevar was aborted, tevar will be performed at a later date.4625-additional surgery - thoracotomy is planned to place an open stent graft in the graft concerned to correct the bending.Medical device problem: 2981-material twisted/bent - graft was reported as bent.Component code 4755-part/component/sub-assembly term not applicable: type of investigation.4114-device not returned: device remains implanted.4110-trend analysis: a 5-year review of similar complaints (appearance>>product defect>>curled/kinked/folds/twisted) gave an occurrence rate of (b)(4) (complaints v sales).4111 - communications/interviews - additional information has been requested from the site, include device details.Investigation findings: 213 - no device problem found- no device details were provided, ct scans were reviewed and no bending of the graft could be confirmed , additional images were requested , however no further imaging was available.Investigation conclusion: 4315 - cause not established- no device details were provided, very limited information was available on this event and scan review did not show the reported bending of the graft we were unable to determine the cause of this event.This is the first event reported for gelweave graft bending.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.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE PLEXUS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 18343546
• MDR Text Key: 331076474
• Report Number: 9612515-2023-00036
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GELWEAVE PLEXUS
• Device Catalogue Number: 73241088/10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male