MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS¿; GELSOFT PLUS STRAIGHT

Model Number 634008P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seroma (2069)

Event Date 05/26/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturers narrative section h6 health effect - clinical code: 2069 - seroma - 2 days post-op the patient came to the hospital with red and hot skin at the area between the anastomosis.The two sutures of the upper and lower anastomosis were unremarkable.Health impact - impact code: 4627 - device explanation - prosthesis explanted, microbiological swab taken by proximal and distal anastomotic area, short part of proximal prosthesis sent to microbiology and the rest is sent back to terumo aortic (not received by terumo aortic yet).Medical device problem code: 2993 - adverse event without identified device or use problem.Component code: 4755 - part/component/sub-assembly term not applicable - the device does not have distinct parts, components, or subassemblies, type of investigation: 4110 - trend analysis.A similar event review was performed for reported post operative seroma occurring in gelsoft branded devices between jan 18 and jun 23.A similar event rate of 0.001% was confirmed.No other complaints have been received relating to the complaint batch and no negative trend was identified.4111 - communication/interviews - further information has been requested from the site.3331- analysis of production records - a review of manufacturing and quality control records confirmed that the device was manufactured to the intended specifications.Investigation findings: 3233 - results pending completion of investigation.

Event Description

Gelsoft plus straight was implanted on (b)(6) 2023.2 days post-op the patient came to the hospital with red and hot skin at the area between the anastomosis.The two sutures of the upper and lower anastomosis were unremarkable.Strong pain ( medically treated).Antibiotic therapy started: leukocytes down, crp constant.Ultrasound with no findings, ct scan: fluid around the implant and swollen lymph nodes.Microbiology without findings.Graft was explanted on (b)(6) 2023 the following was noticed during explant procedure: cloudy accumulation of fluid, in the area of the dist.Anastomosis significantly more.White structures ( fibrin ).Prosthesis explanted, microbiological swab taken by proximal and distal anastomotic area, short part of proximal prosthesis sent to microbiology and the rest is sent back to terumo aortic (not received by terumo aortic yet) new bypass with oniflow prosthesis implanted.Additional information received on 05.06.2023: the intraoperative wound swab is negative, no pathogens detectable.The symptoms were significantly reduced the day after the explant.

Manufacturer Narrative

Manufacturers narrative: section h6.Health effect - clinical code: 2069 - seroma - 2 days post-op the patient came to the hospital with red and hot skin at the area between the anastomosis.The two sutures of the upper and lower anastomosis were unremarkable.Health impact - impact code: 4627 - device explanation - prosthesis explanted, microbiological swab taken by proximal and distal anastomotic area, short part of proximal prosthesis sent to microbiology and the rest is sent back to terumo aortic (not received by terumo aortic yet).Medical device problem code: 2993 - adverse event without identified device or use problem.Component code: 4755 - part/component/sub-assembly term not applicable - the device does not have distinct parts, components, or subassemblies.Type of investigation: 4110 - trend analysis.A similar event review was performed for reported post operative seroma occurring in gelsoft branded devices between jan 18 and jun 23.A similar event rate of 0.001% was confirmed.No other complaints have been received relating to the complaint batch and no negative trend was identified.4111 - communication/interviews - further information has been requested from the site.3331- analysis of production records - a review of manufacturing and quality control records confirmed that the device was manufactured to the intended specifications 10 testing of actual/suspected device: investigation findings: 213 - no device problem found: the exact cause of fluid build-up around the implanted device could not be determined.However, it could be reasonably concluded that this was not due to any flaws in the structure of the device.Investigation conclusion: 4310 - caused trace to non-device related factors: the exact cause of fluid build-up around the implanted device could not be determined.However, it could be reasonably concluded that this was not due to any flaws in the structure of the device.

Event Description

Gelsoft plus straight was implanted on (b)(6) 2023.2 days post-op the patient came to the hospital with red and hot skin at the area between the anastomosis.The two sutures of the upper and lower anastomosis were unremarkable.- strong pain ( medically treated).- antibiotic therapy started: leukocytes down, crp constant.- ultrasound with no findings, ct scan: fluid around the implant and swollen lymph nodes.- microbiology without findings.Graft was explanted on (b)(6) 2023 the following was noticed during explant procedure: - cloudy accumulation of fluid, in the area of the dist.Anastomosis significantly more.- white structures ( fibrin ).Prosthesis explanted, microbiological swab taken by proximal and distal anastomotic area, short part of proximal prosthesis sent to microbiology and the rest is sent back to terumo aortic (not received by terumo aortic yet) new bypass with oniflow prosthesis implanted.Additional information received on 05.06.2023: the intraoperative wound swab is negative, no pathogens detectable.The symptoms were significantly reduced the day after the explant.R&d analysis/ investigation finding's 23 aug 2023.The exact cause of fluid build-up around the implanted device could not be determined.However, it could be reasonably concluded that this was not due to any flaws in the structure of the device.An infrequent response to graft implantation is seroma formation around the graft.The exact cause of this is not known.The evidence provided by the hospital suggests that a seroma has formed around this graft.Unfortunately, the cause of seroma formation could not be further investigated because of the way in which the graft was returned to terumo aortic.For proper investigation to have taken place the graft should have been returned in formalin solution.This report has been submitted as final for mfg.Report fda 9612515-2023-00004 to provide correction to device details.

Event Description

Gelsoft plus straight was implanted on (b)(6) 2023.2 days post-op the patient came to the hospital with red and hot skin at the area between the anastomosis.The two sutures of the upper and lower anastomosis were unremarkable.Strong pain ( medically treated).Antibiotic therapy started: leukocytes down, crp constant.Ultrasound with no findings, ct scan: fluid around the implant and swollen lymph nodes.Microbiology without findings.Graft was explanted on (b)(6) 2023 the following was noticed during explant procedure: cloudy accumulation of fluid, in the area of the dist.Anastomosis significantly more.White structures ( fibrin ).Prosthesis explanted, microbiological swab taken by proximal and distal anastomotic area, short part of proximal prosthesis sent to microbiology and the rest is sent back to terumo aortic (not received by terumo aortic yet) new bypass with oniflow prosthesis implanted.Additional information received on 05.06.2023: the intraoperative wound swab is negative, no pathogens detectable.The symptoms were significantly reduced the day after the explant.This report has been submitted as follow up 1 for mfg.Report fda 9612515-2023-00004 to provide correction to device details.

Manufacturer Narrative

Manufacturers narrative: section h6 health effect - clinical code: 2069 - seroma - 2 days post-op the patient came to the hospital with red and hot skin at the area between the anastomosis.The two sutures of the upper and lower anastomosis were unremarkable.Health impact - impact code: 4627 - device explanation - prosthesis explanted, microbiological swab taken by proximal and distal anastomotic area, short part of proximal prosthesis sent to microbiology and the rest is sent back to terumo aortic (not received by terumo aortic yet).Medical device problem code: 2993 - adverse event without identified device or use problem.Component code: 4755 - part/component/sub-assembly term not applicable - the device does not have distinct parts, components, or subassemblies.Type of investigation: 4110 - trend analysis.(b)(4).4111 - communication/interviews - further information has been requested from the site.3331- analysis of production records - a review of manufacturing and quality control records confirmed that the device was manufactured to the intended specifications investigation findings: 3233 - results pending completion of investigation.

• Brand Name: GELSOFT PLUS¿
• Type of Device: GELSOFT PLUS STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• 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: 17223849
• MDR Text Key: 318075624
• Report Number: 9612515-2023-00004
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115191
• UDI-Public: 05037881115191
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2023

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 Model Number: 634008P
• Device Catalogue Number: 634008P-G
• Device Lot Number: 25175911
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 05/30/2023; 05/30/2023
• Supplement Dates FDA Received: 07/27/2023; 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2023
• 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: 62 YR
• Patient Sex: Female