MAUDE Adverse Event Report: VASCUTEK LTD GELFOST PLUS STRAIGHT

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hematemesis (4478)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

Manufactures narrative clinical code: 4478 - hematemesis - as reported aorta-duodenal fistula with hematemesis in 2022.Impact code: 4625 - additional surgery - surgical intervention: endovascular reintervention by stent in 2022, and open repair at a later date in 09-2023 (tube prosthesis -> bifurcated prosthesis).Two separate reinterventions.Medical device problem: 3190 - insufficient information - a/w additional information from the site component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis - a 5 year review of similar complaints (medical event > other) gave an occurrence rate of <0.001% (complaints v sales).3331 - analysia of production records - full batch review was performed, no issues were identified from raw material to finished product during manufacturing process.4111 - communication/interviews - addition information was received on 08 mar 24; this confirmed that the patient is not under treatment anymore.The original graft was removed and replaced for a bifurcated graft.This can reasonably be assumed, as the location of a aorto-duodenal fistula is proximally, and to place a bifurcated graft, the tube graft should have been removed.There was no damage to graft during implant and aorto-duodenal fistulas are a known late complication in aortic aneurysm repair (open surgery or evar), therefore it is suspected that the complication is possibly device related.If no aortic repair surgery had taken place, the chances of this happening, because of a ruptured aaa that ruptured to the duodenum, would be very low.4114 - device not returned - device was explanted out with the study as patient had 2 procedure out with the study.

Event Description

As reported panther study: event reported as "possibly related to device" but no device deficiency reported, aorta-duodenal fistula with hematemesis in 2022.Note: subject had telephone follow up for 5 year follow up visit - this is when this adverse event was discovered by site.Subject was treated at different hospitals for both the endovascular and open surgical repair and the study site do not have further information at this time.Surgical intervention: endovascular reinterventon by stent in 2022, and open repair at a later date in (b)(6) 2023 (tube prosthesis -> bifurcated prosthesis).Two separate reinterventions.

Event Description

As reported panther study: event reported as "possibly related to device" but no device deficiency reported, aorta-duodenal fistula with hematemesis in 2022.Note: subject had telephone follow up for 5 year follow up visit - this is when this adverse event was discovered by site.Subject was treated at different hospitals for both the endovascular and open surgical repair and the study site do not have further information at this time.Surgical intervention: endovascular reinterventon by stent in 2022, and open repair at a later date in (b)(6) 2023 (tube prosthesis - bifurcated prosthesis).Two separate reinterventions.This report is being submitted as a final for manufacturing report #9612515-2024-00020 to provide event closure information for (b)(4).

Manufacturer Narrative

Manufactures narrative: clinical code: 4478 - hematemesis - as reported aorta-duodenal fistula with hematemesis in 2022.Impact code: 4625 - additional surgery - surgical intervention: endovascular reintervention by stent in 2022, and open repair at a later date in (b)(4) 2023 (tube prosthesis - bifurcated prosthesis).Two separate reinterventions.4644 - medication required - the patient was given acetylsalicylzuur.Medical device problem: 2993 - adverse event without identified device or use problem - event was reported as possibly device related but no device deficiency as reported.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis - a 5 year review of similar complaints (medical event - other) gave an occurrence rate of (b)(4) (complaints v sales).No negative trend in the number of complaints received has been identified.3331 - analysis of production records - full batch review was performed, no issues were identified from raw material to finished product during manufacturing process.4111 - communication/interviews - addition information was received on (b)(4) 2024; this confirmed that the patient is not under treatment anymore.The original graft was removed and replaced for a bifurcated graft.This can reasonably be assumed, as the location of a aorto-duodenal fistula is proximally, and to place a bifurcated graft, the tube graft should have been removed.There was no damage to graft during implant and aorto-duodenal fistulas are a known late complication in aortic aneurysm repair (open surgery or evar) endovascular aneurysm repar, therefore it is suspected that the complication is possibly device related.If no aortic repair surgery had taken place, the chances of this happening, because of a ruptured (aaa) abdominal aortic aneurysm that ruptured to the duodenum, would be low.The patient outcome was resolved with sequelae and the adverse event end date was 05 mar 24.4114 - device not returned - device was explanted out with the study as patient had 2 procedure out with the study investigation findings: 3221 - no findings available - due to the scans not being made available and the device being explanted out with the study we could not complete a full investigation.No causal link was could be identified between the event and the device.Investigation conclusion: 4315 - cause not established - due to the scans not being made available and the device being explanted out with the study we could not complete a full investigation.No causal link was could be identified between the event and the device.

• Brand Name: GELFOST PLUS STRAIGHT
• Type of Device: GELFOST PLUS STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 19010379
• MDR Text Key: 338983735
• Report Number: 9612515-2024-00020
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115252
• UDI-Public: 05037881115252
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 633014P
• Device Lot Number: 16363561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2017
• 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
• Patient Age: 60 YR
• Patient Sex: Male