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

Catalog Number 633010P-G

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 03/29/2022

Event Type  Injury  

Event Description

Clinical study_panther_31 with superinfected lymphocele abscess at the left scarpa with infection of the prosthesis.Germ: streptococcus dysgalactiae surgical intervention required: evacuation of superinfected lymphocele in the left scarpa under general anesthesia.Patient outcome to be confirmed.No specific device deficiency reported.Suspected infection of graft.Patient attended 1 year follow up visit on (b)(6) 2023 with no new adverse events to report.No imaging performed at visit.Procedure related/ possibly device and pre-existing condition.Surgical intervention was required.

Manufacturer Narrative

Manufacturer narrative: clinical code: 4580 - insufficient information: a/w additional information form site.Impact code: 4624 - surgical intervention: evacuation of superinfected lymphocele in the left scarpa under general anaesthesia.Medical device problem: 3190 - insufficient information: a/w additional information form site.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 5 year review of similar complaints (gelsoft plus sales from jan 19 to nov 23 vs infection medical event>infection jan 19 to jan 24 complaints) gave an occurrence rate of (b)(4).4111 - communication interview: additional information from site received on 04 jan 24: before implant (1day) the patient was given cefazoline / after infection: tazocilline 1 week; daptomycine 1 week; amoxicillin.The graft was implanted in the femoral artery to popliteal artery.The patient was present with infection 12 days after implant.Cultures taken from infected graft indicated streptococcus dysgalactiae 3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture from raw material to finished products 4114.

Manufacturer Narrative

Manufacturer narrative: clinical code: 2446 - post operative wound infection: according to 301-199 polyester multi-product row gelita set b section 1.5.Potential adverse event; infection of prosthesis is considered as known and expected complication.Impact code: 4624 - surgical intervention: evacuation of superinfected lymphocele in the left scarpa under general anaesthesia.Medical device problem: 3191 - appropriate term/code not available: according to 301-199 polyester multi-product row gelita set b section 1.5.Potential adverse event; infection of prosthesis is considered as known and expected complication.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 5 year review of similar complaints (gelsoft plus sales from jan 19 to nov 23 vs infection medical event: infection jan 19 to jan 24 complaints) gave an occurrence rate of 0.006% 4111 - communication interview: additional information from site received on 04 jan 24: before implant (1day) the patient was given cefazoline / after infection: tazocilline 1 week; daptomycine 1 week; amoxicillin.The graft was implanted in the femoral artery to popliteal artery.The patient was present with infection 12 days after implant.Cultures taken from infected graft indicated streptococcus dysgalactiae.3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture from raw material to finished products.4114 - device not returned: device remains implanted.Investigation findings: 4247 - appropriate term/code not available: according to 301-199 polyester multi-product row gelita set b section 1.5.Potential adverse event; infection of prosthesis is considered as known and expected complication.Investigation conclusion: 22 - known inherent risk of device: according to 301-199 polyester multi-product row gelita set b section 1.5.Potential.Adverse event; infection of prosthesis is considered as known and expected complication.

Event Description

Clinical study_panther_31 with superinfected lymphocele abscess at the left scarpa with infection of the prosthesis.Germ: streptococcus dysgalactiae surgical intervention required: evacuation of superinfected lymphocele in the left scarpa under general anesthesia.Patient outcome to be confirmed.No specific device deficiency reported.Suspected infection of graft.Patient attended 1 year follow up visit on (b)(6) 2023 with no new adverse events to report.No imaging performed at visit.Procedure related/ possibly device and pre-existing condition.Surgical intervention was required.This report is being submitted to provide i final information for closure of mfg report #912515-2024-00004.

• Brand Name: GELSOFT PLUS STRAIGHT
• Type of Device: GELSOFT PLUS STRAIGHT
• 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: 18613675
• MDR Text Key: 334206556
• Report Number: 9612515-2024-00004
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K830016
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2002
• Device Catalogue Number: 633010P-G
• Device Lot Number: 17871215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2019
• 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: 74 YR
• Patient Sex: Male