MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID

Model Number UNKNOWN

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2004

Event Type  Injury  

Event Description

Patient previously had open ascending repair and relevant medical history of dissection.Post operative to that procedure (uk dos) patient developed additional type a dissection at anastomosis line and additional tear at apex of the arch.Patient showed on that scan a compressed tl with the tl on the inner curve of the arch.Distal landing zone was estimated at 150mm from zone 2 where the scan showed the tlmax = 29mm and aortic outer wall diameter averaging 36mm.Thus a 30/32/150mm plexus was chosen as the device size for fet.Patient was evaluated for fet/total arch repair which was performed on (b)(6) 2024 with 30/32/150mm plexus configuration at zone 2.Post operative scan from (b)(6) 2024 indicated graft was severely compressed in the tl.Physician is consulting with vascular partner to consider adjunctive ballooning and/or future tevar.Patient outcome no clinical sequalae has been communicated other than radiologic finding of graft compression/collapse.

Manufacturer Narrative

Clinical code: 4580 insufficient information: a/w scans and additional information from site.Impact code: 4624 surgical intervention: patient was evaluated for fet/total arch repair which was performed on (b)(6) 2024 with 30/32/150mm plexus configuration at zone 2.Post operative scan from (b)(6) 2024 indicated graft was severely compressed in the tl.Physician is consulting with vascular partner to consider adjunctive ballooning and/or future tevar.Medical device problem: 3190 insufficient information: a/w scans and additional information from site.Component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 4110 trend analysis: a 5 year review of similar complaints (appearance > product defect > other) gave an occurrence rate of less than (b)(4) (complaints v sales).No negative trend in the number of complaints received has been identified.4111 communication/interviews: a/w scans and additional information from site.3331 analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4114 device not returned: device remains implanted.

Event Description

Patient previously had open ascending repair and relevant medical history of dissection.Post operative to that procedure (uk dos) patient developed additional type a dissection at anastomosis line and additional tear at apex of the arch.Patient showed on that scan a compressed tl with the tl on the inner curve of the arch.Distal landing zone was estimated at 150mm from zone 2 where the scan showed the tlmax = 29mm and aortic outer wall diameter averaging 36mm.Thus a 30/32/150mm plexus was chosen as the device size for fet.Patient was evaluated for fet/total arch repair which was performed on 1/17/24 with 30/32/150mm plexus configuration at zone 2.Post operative scan from 1/21/24 indicated graft was severely compressed in the tl.Physician is consulting with vascular partner to consider adjunctive ballooning and/or future tevar.Patient outcome no clinical sequalae has been communicated other than radiologic finding of graft compression/collapse.This report has been submitted as a final for mfg.Report fda 9612515-2024-00008 to provide investigation outcome details.

Manufacturer Narrative

Clinical code 4582 - patient showed no clinical signs, symptoms or conditions.No clinical sequalae has been communicated other than radiologic finding of graft compression/collapse impact code: 4624 surgical intervention: patient was evaluated for fet/total arch repair which was performed on (b)(6) 2024 with 30/32/150mm plexus configuration at zone 2.Post operative scan from (b)(6) 2024 indicated graft was severely compressed in the tl.Physician is consulting with vascular partner to consider adjunctive ballooning and/or future tevar.Product was ballooned and additional stent was placed (not a terumo stent).That procedure was done because of the radiographic images showing the graft compressed.Medical device problem: 1583 - inadequacy of device size / shape due to patient anatomy.Scans provided showed the device used was not compatible with the patients anatomy causing compression of the device.Component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 4110 trend analysis: a 5 year review of similar complaints (appearance > product defect > other) gave an occurrence rate of less than 0.000% (complaints v sales).No negative trend in the number of complaints received has been identified.4111 communication/interviews: scans were provided for review.3331 analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device 4114 device not returned: device remains implanted.Investigation findings: 213 - no device problem found - the incident was found to be not device related.Scans provided showed the device used was not compatible with the patients anatomy causing compression of the device.Investigation conclusions: 4310 - not device related - the incident was found to be not device related.Scans provided showed the device used was not compatible with the patients anatomy causing compression of the device.

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID
• 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: 18729299
• MDR Text Key: 335712013
• Report Number: 9612515-2024-00008
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: THP3032X150A-G
• Device Lot Number: 25368931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2023
• 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: 58 YR
• Patient Sex: Male