MAUDE Adverse Event Report: VASCUTEK LTD.; GELSOFT PLUS BIFURCATE

Catalog Number 631407P

Device Problem Off-Label Use (1494)

Patient Problem Failure of Implant (1924)

Event Date 04/13/2022

Event Type  Injury  

Manufacturer Narrative

Clinical code: 1924 malfunction of a medical implant: elongation and tortuosity of graft pushing against the skin lead to infection which led to two major surgeries.First to clean the site and foreshorten the graft.The second to re-do the entire procedures.Health impact: 4627 device explanation: device was explanted from patient on (b)(6) 2022 medical device problem code: 1494 off label use: as reported on intake form note: suspected off label use as gelsoft plus bifurcate is indicated for abdominal vessel replacement only in usa ifu type of investigation: 4110 trend analysis: a similar event review was completed for this event; this gave an occurrence rate of 0.007%.This showed no negative trend 3331 analysis of production records: a batch review was performed which showed this device was built to specification 4114 device not returned: marked on intake form that device was not available for return.

Event Description

Occlusive disease - aorto-axillary.Panther study post market study.3/1/33 s/p ascending aorta to ica bypass, ascending to right axillary artery bypass.Right common femoral vein access.On 4/1/22 presented to clinic for drainage.Surgery (b)(6) 2022 neck exploration and washout for tortuosity and elongation of graft pushing against tissue.On (b)(6) a total redo of surgery.The graft had elongated and was pushing against and eroding the skin.Infection related to tortuosity and elongation of the graft resulting in infection and redo of entire procedure.Pi reported deficiency to bms at time the incident occurred.Reintervention #1: a 3 cm long incision was made along the old incision and immediately upon opening the skin, the graft was exposed.The area was drained and irrigated with saline solution as well as betadine solution.It appeared that the graft severe tortuosity which was pushing against the subcutaneous tissue towards the skin eroding through the platysma and subcutaneous tissue.Thus the decision was made to resect the graft to foreshorten.Three cm of the graft was excised the graft was then reanastomosed, sutured, irrigated and the wound was closed.Reintervention #2: explanation of infected aorto-carotid and axillary grafts.Redo ascending aorta to right carotid and right axillary artery bypass grafting with cardiopulmonary bypass and circulatory arrest.Redo right carotid dissection.Redo axillary artery dissection.Device failure: yes, elongation and tortuosity of graft pushing against the skin lead to infection which led to two major surgeries.First to clean the site and foreshorten the graft.The second to re-do the entire procedures procedure related: possibly, pre-existing condition: no, surgical intervention was required.Event date: (b)(6) 2022, implant date: (b)(6) 2022, explant date: (b)(6) 2022.

Event Description

Occlusive disease - aorto-axillary.Panther study post market study: 3/1/33 s/p ascending aorta to ica bypass, ascending to right axillary artery bypass.Right common femoral vein access.On (b)(6) 2022, presented to clinic for drainage.Surgery on (b)(6) 2022, neck exploration and washout for tortuosity and elongation of graft pushing against tissue.On (b)(6), a total redo of surgery.The graft had elongated and was pushing against and eroding the skin.Infection related to tortuosity and elongation of the graft resulting in infection and redo of entire procedure.Pi reported deficiency to bms at time the incident occurred.Reintervention #1: a 3 cm long incision was made along the old incision and immediately upon opening the skin, the graft was exposed.The area was drained and irrigated with saline solution as well as betadine solution.It appeared that the graft severe tortuosity which was pushing against the subcutaneous tissue towards the skin eroding through the platysma and subcutaneous tissue.Thus the decision was made to resect the graft to foreshorten.Three cm of the graft was excised the graft was then reanastomosed, sutured, irrigated and the wound was closed.Reintervention #2: explanation of infected aorto-carotid and axillary grafts.Redo ascending aorta to right carotid and right axillary artery bypass grafting with cardiopulmonary bypass and circulatory arrest.Redo right carotid dissection.Redo axillary artery dissection.Device failure: yes, elongation and tortuosity of graft pushing against the skin lead to infection which led to two major surgeries.First to clean the site and foreshorten the graft.The second to re-do the entire procedures procedure related: possibly, pre-existing condition: no, surgical intervention was required.Event date: 13 apr 2022, implant date: on (b)(6) 2022, explant date: on (b)(6) 2022.This report is being submitted to provide final complaint closure information for manufacturing comp no: 9612515-2023-00011, (b)(4).

Manufacturer Narrative

Clinical code: 1924 malfunction of a medical implant: elongation and tortuosity of graft pushing against the skin lead to infection which led to two major surgeries.First to clean the site and foreshorten the graft.The second to re-do the entire procedures.Health impact: 4627 device explanation: device was explanted from patient on (b)(6) 2022.Medical device problem code: 1494 off label use: as reported on intake form note: suspected off label use as gelsoft plus bifurcate is indicated for abdominal vessel replacement only in usa ifu.Component code: 4755 part/component/sub-assembly term no applicable: type of investigation: 4110 trend analysis: a similar event review was completed for this event; this gave an occurrence rate of (b)(4).This showed no negative trend.3331 analysis of production records: a batch review was performed which showed this device was built to specification.4114 device not returned: marked on intake form that device was not available for return.4111 communication/interviews: emails received on 20th july 2023 and 22nd aug 2023 from site with additional information.Investigation findings: 4247 appropriate term / code not available: from surgery notes on (b)(6) 2022, did not indicate soak in sterile saline solution as stated in ifu 301-174_3- multiproduct usa ifu - section 1.4 warning and precautions, point 2.Investigation conclusion: 18 failure to follow instructions: from surgery notes on (b)(6) 2022, did not indicate soak in sterile saline solution as stated in ifu 301-174_3- multiproduct usa ifu - section 1.4 warning and precautions, point 2.

• Type of Device: GELSOFT PLUS BIFURCATE
• 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; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 17547640
• MDR Text Key: 321132667
• Report Number: 9612515-2023-00011
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115511
• UDI-Public: 05037881115511
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

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: Health Professional
• Device Expiration Date: 11/17/2020
• Device Catalogue Number: 631407P
• Device Lot Number: 21580230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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: 67 YR
• Patient Sex: Female