MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID; THORAFLEX HYBRID PLEXUS

Model Number THORAFLEX HYBRID

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2020

Event Type  Injury  

Event Description

Clinical trial thor, site number: (b)(4) hannover patient number: (b)(6) - endoleak type 1b - medical condition before procedure (hypertension, cerebrovascular disease, previous stroke) resolved without sequalae.

Manufacturer Narrative

Manufacturer narrative: clinical code: 4580 - insufficient information: a/w additional information form site.Impact code: 4624 -surgical intervention : no intra op angiogram was carried out.Endoloeak was observed at 1 year follow up.Thoracoabdominal aortic replacement was performed , event resolved without sequalae.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 (thoraflex hybrid sales v thoraflex hybrid type 1b endoleak events from jan 19 to feb 24 gave an occurrence rate of (b)(4).4111 - communication interview: additional information.3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture.4114 - device not returned: device remains implanted.

Manufacturer Narrative

Manufacturer narrative: clinical code: 4580 - insufficient information: a/w additional information form site.Impact code: 4624 -surgical intervention : no intra op angiogram was carried out.Endoloeak was observed at 1 year follow up.Thoracoabdominal aortic replacement was performed , event resolved without sequalae.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 (thoraflex hybrid sales v thoraflex hybrid type 1b endoleak events from jan 19 to feb 24 gave an occurrence rate of (b)(4).4111 - communication interview: additional information.3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture.4114 - device not returned: device remains implanted.Investigation findings: 213 - no device problem found: no issues were found on review of all retained manufacturing and qc records for this device.Investigation conclusion : 19 - user error - scans were returned and reviewed on (b)(6) 2024 - a thoraflex hybrid device was implanted to treat a type a aortic dissection.The patient had a pre-existing tevar device implanted in the proximal descending aorta.The stented section of the thoraflex hybrid device appears to have a sufficient overlap with the tevar device however there appears to be insufficient oversize, based on diameter measurements of the tevar device taken from the pre-implant ct scan (b)(6) 2019).As a result of the insufficient oversizing, there is potentially a small type b endoleak located at the inner curve at the junction of the thoraflex hybrid and tevar devices.Additional information added to section b7 - patient pre-condition.Additional information added to section b7 - patient pre-condition.

Event Description

Clinical trial thor, site number 001 hannover patient number 016 - endoleak type 1b - medical condition before procedure (hypertension, cerebrovascular disease, previous stroke) resolved without sequalae.This report is being submitted as follow up #1 for mfg.Report #9612515-2024-00017 to provide event closure information for comp no (b)(4).

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID PLEXUS
• 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: 18984885
• MDR Text Key: 338661185
• Report Number: 9612515-2024-00017
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P210006
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Model Number: THORAFLEX HYBRID
• Device Catalogue Number: THP3038X100B
• Device Lot Number: 17376335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2018
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Male