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

Model Number GELSOFT PLUS STRAIGHT

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

Patient Problem Unspecified Infection (1930)

Event Date 06/26/2022

Event Type  Injury  

Event Description

This event was reported via vascutek ltd's panther study programme as follows: wound infection was detected at the groin area - bypass tunnel infection and thigh infection (distally).The gelsoft plus straight vascular prosthesis was implanted on (b)(6) 2022.On (b)(6) 2022 a wound infection of the groin was detected - bypass tunnel and thigh (distally) was detected.This event was reported as related to the procedure and device and possibly related to a patient pre-existing condition.Four wound revision/irrigation procedures was performed.The wound was treated with negative wound therapy (over 14 days).

Manufacturer Narrative

(b)(4).

Event Description

This event was reported via vascutek ltd's panther study programme on 22 jul 22 as follows: wound infection was detected at the groin area - bypass tunnel infection and thigh infection (distally).The gelsoft plus straight vascular prosthesis was implanted on (b)(6) 2022.On 26 jun 22 a wound infection of the groin was detected - bypass tunnel and thigh (distally).This event was reported to vascutek as related to the procedure and device and possibly related to a patient pre-existing condition.Four wound revision/irrigation procedures was performed.The wound was treated with negative wound therapy (over 14 days).

Manufacturer Narrative

Section b5 event description has been adjusted to include the date that this event notification was received by vascutek ltd.Section d6 (a) had an incorrect date displayed as (b)(6) 2022.The correct date is (b)(6) 2022.

Event Description

This event was reported via vascutek ltd's panther study programme on 22 jul 22 as follows: wound infection was detected at the groin groin area - bypass tunnel infection and thigh infection (distally).The gelsoft plus straight vascular prosthesis was implanted on (b)(6) 2022.On (b)(6) 2022 a wound infection of the groin was detected - bypass tunnel and thigh (distally).This event was reported to vascutek as related to the procedure and device and possibly related to a patient pre-existing condition.Four wound revision/irrigation procedures were performed.The wound was treated with negative wound therapy (over 14 days).Graft was explanted on (b)(6) 2022.

Manufacturer Narrative

Type of investigation: 4112 - analysis of data provided by user/third party - further information / biopsy results was provided by the site - the affected graft was explanted on (b)(6) 2022 and is unavailable for return to vascutek ltd.For analysis.The site tested the wound on multiple occasions during the treatment process (b)(6) 2022, to identify the cause of the reported infection.No indication of infection or incipient sepsis was found.It was indicated that the graft was rejected by the patient's body (clinical opinion of the site).However it was not indicated/confirmed if the patient was allergic too or exhibited sensitivity to polyester or materials of bovine origin (the grafts constructed materials).Swab testing of the wound site did identify the bacteria klebsiella oxytoca.Vascutek ltd.'s environmental monitoring and bioburden testing has never detected klebsiella oxytoca within its manufacturing processes.A review of this type of bacteria indicates that it is common to wound site infections.4114 - device not accessible for testing - the graft was explanted and is not available.Investigation findings: 213 - no device problem found - no issue has been found upon review of the retained device / sterilisation history records and available information provided by the site.Investigation conclusions: 67 - no problem detected - the device was manufactured to specifications.Vascutek ltd.Products are sterilised using 100% ethylene oxide which is a bactericidal chemical.The sterilization process is fully validated ensuring a sterility assurance level (sal) of 10-6 using bacillus atrophaeus biological indicators.As no issues with the sterile barrier packaging was reported to us, this would indicate that when the graft was opened from its protective packaging, it was sterile.Site also confirmed that the device was rejected by the patients body and therefore this event is not device related.22 - known inherent risk of device - post operative infections are a known and expected complication following any invasive procedure.Infection is also documented within the device ifu as a potential adverse event.

• Brand Name: GELSOFT PLUS
• Type of Device: GESLOFT PLUS STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, renrewshire PA49R-R ; UK PA49RR
• MDR Report Key: 15223752
• MDR Text Key: 297864668
• Report Number: 9612515-2022-00012
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115177
• UDI-Public: 05037881115177
• 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: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2022

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: 07/31/2024
• Device Model Number: GELSOFT PLUS STRAIGHT
• Device Catalogue Number: 634006P-G
• Device Lot Number: 21945820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/16/2022; 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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