MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID; THORAFLEX HYBRID ANTE- FLO

Model Number THORAFLEC HYBRID

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

Patient Problem Atrial Fibrillation (1729)

Event Date 12/31/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturers narrative: clinical code : 1729 - atrial fibrillation - event reported from study site as atrial fibrillation.Impact code : 4648 - insufficient information - the site have stated patient has recovered with treatment , awaiting information on what treatment was performed.Medical device problem code: 2993- adverse event without identified device or use problem - no device deficiency has been reported.Component code: 4755 - part component / sub- assembly term not applicable - device has no component parts type of investigation 4109 - historical data analysis- this is the first event of atrial fibrillation reported in thoraflex hybrid devices (b)(6).4110 - trend analysis- a 5 year similar event review was performed for medical event>atrial fibrillation in thoraflex hybrid devices (b)(6).A similar event rate of (b)(4) was confirmed.4111- communication / interviews- further information has been requested on the treatment to resolve this issue.3331 - analysis of production records- review of all retained device records showed no issues.4114 - device not returned- device remains in -situ.

Event Description

Automated e-mail notification received from study database on (b)(6) 2024 reporting the event of atrial fibrillation from (b)(6) 2023.Information provided from site was - diagnosed with new onset afib w/ rvr.This is still unresolved and still being treated.The subject remains in the study.An export of the information available in the study database for this subject to date has been provided separately.No surgical interventions.The ae is still ongoing and is unresolved and being treated.The subject remains in the study.The site have not completed the device deficiency ecrf.

Manufacturer Narrative

Manufacturers narrative clinical code : 1729 - atrial fibrillation - event reported from study site as atrial fibrillation.Impact code : 4648 - insufficient information - the site have stated patient has recovered with treatment , awaiting information on what treatment was performed.Medical device problem code: 2993- adverse event without identified device or use problem - no device deficiency has been reported.Component code: 4755 - part component / sub- assembly term not applicable - device has no component parts.Type of investigation 4109 - historical data analysis- this is the first event of atrial fibrillation reported in thoraflex hybrid devices jan 19 - jan 24.4110 - trend analysis- a 5 year similar event review was performed for medical event>atrial fibrillation in thoraflex hybrid devices jan 19 - jan 24.A similar event rate of 0.000% was confirmed.4111- communication / interviews- further information has been requested on the treatment to resolve this issue.3331 - analysis of production records- review of all retained device records showed no issues.4114 - device not returned- device remains in -situ.Investigation findings 213 - no device problem found - review of all retained manufacturing and quality records show the graft was manufactured to specification.Investigation conclusion 4310 - cause traced to non-device related factors - further information was received from the site stating there was no device deficiency 4311 - adverse event related to procedure - further information received from the site event reported is possibly related to the whole procedure.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints.Trending and reporting process and if an adverse trend develops action may be taken at that time.

Event Description

Automated e-mail notification received from study database on 02 january 2024 reporting the event of atrial fibrillation from 31 dec 2023.Information provided from site was - diagnosed with new onset afib w/ rvr.This is still unresolved and still being treated.The subject remains in the study.An export of the information available in the study database for this subject to date has been provided separately.No surgical interventions.The ae is still ongoing and is unresolved and being treated.The subject remains in the study.The site have not completed the device deficiency ecrf.This report is being submitted as follow up #1 for mfg report number 9612-2024-00006 to provide closure information for comp # (b)(4).

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID ANTE- FLO
• 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 business park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 18604522
• MDR Text Key: 334026860
• Report Number: 9612515-2024-00002
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: THORAFLEC HYBRID
• Device Catalogue Number: THA2830X150A
• Device Lot Number: 25191174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female