MAUDE Adverse Event Report: VASCUTEK LTD. GELSEAL STRAIGHT; GELSOFT PLUS THIN WALL

Model Number GELSOFT PLUS THIN WALL

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturers narrative section h6 clinical code 4582 - blood loss reported from centre of graft implanted on (b)(6) 2023, event date on (b)(6) 2023.Impact code: 4607 - patient was re admitted to hospital and the graft was explanted and replaced with a propaten (gore) graft.Patient has recovered.Medical device problem: 3191 - leakage from the body of the graft near the centre.Component code: 4755 part/component/sub-assembly term not applicable: -device has no component parts.Type of investigation: 4110- trend analysis: a 5-year review of similar complaints (leakage) gave an occurrence (b)(4) (complaints v sales).As this is the only leakage complaint received.No negative trend in the number of complaints received has been identified.3331- analysis of production records: device history records were reviewed which showed no issues with product 4114 -device not returned: graft was explanted , however is not available to be returned for analysis.

Event Description

Hematoma due to blood leakage from the graft: the patient underwent axillofemoral bypass surgery four years ago.As a hematoma was noted, thoracotomy was performed to determine the cause and blood leakage was observed from three points in the centre of the graft.The graft where leakage occurred was therefore replaced with a propaten graft (gore).The surgeon requested information about the occurrence of similar events.The patient is recovered.

Manufacturer Narrative

Manufacturers narrative: section h6.Clinical code: 4581 - blood loss reported from centre of graft implanted (b)(6) 2023 event date 05 oct 2023.Impact code: 4607 - patient was re admitted to hospital and the graft was explanted and replaced with a propaten (gore) graft.Patient has recovered.Medical device problem: 3191 - leakage from the body of the graft near the centre.Component code: 4755 part/component/sub-assembly term not applicable: -device has no component parts.Type of investigation.4110- trend analysis: a 5-year review of similar complaints (leakage) gave an occurrence rate of <0.001% (complaints v sales).As this is the only leakage complaint received.No negative trend in the number of complaints received has been identified.4114 -device not returned: graft was explanted , however is not available to be returned for analysis.4111- communication/interview: revised infromation sent by site confimred update to product and item number which determined a vigilance reportability review.This product is not marketed in usa thereforre this i not a reportable event to fda.Investigation findings: 4247 - appropriate term/code not available: revised infromation sent by site confimred update to product and item number which determined a vigilance reportability review.This product is not marketed in usa thereforre this i not a reportable event to fda.Investigation conclusion: 4316 - appropriate term/code not available: revised infromation sent by site confimred update to product and item number which determined a vigilance reportability review.This product is not marketed in usa thereforre this i not a reportable event to fda.

Event Description

Hematoma due to blood leakage from the graft: the patient underwent axillofemoral bypass surgery four years ago.As a hematoma was noted, thoracotomy was performed to determine the cause and blood leakage was observed from three points in the centre of the graft.The graft where leakage occurred was therefore replaced with a propaten graft (gore).The surgeon requested information about the occurrence of similar events.The patient is recovered.This report is being submitted as final for mfg report #9612515-2023-00029 to provide event closure information forcomp 5156.

• Brand Name: GELSEAL STRAIGHT
• Type of Device: GELSOFT PLUS THIN WALL
• 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; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 18049130
• MDR Text Key: 327127610
• Report Number: 9612515-2023-00029
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P890045
• 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: 12/18/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: GELSOFT PLUS THIN WALL
• Device Catalogue Number: 628010TN
• Device Lot Number: 2002091281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female