MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID

Catalog Number THP3036X100J

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2023

Event Type  Injury  

Manufacturer Narrative

Manufacture's narrative: clinical code: 4852 no clinical signs, symptoms or conditions: no health damage to the patient.Impact code: 2199 no health consequences or impact: no health damage to the patient.Medical device problem: 3190 insufficient information: a/w additional information from site and scan review.Component code: 4755 part/component/sub-assembly term not applicable: type of investigation: 4114 device not returned: device remains implanted.3331 analysis of production records: no issue found when batch review was performed 4109 historical data analysis: no issue found when batch review was performed.4110 trend analysis: a 5-year review of similar complaints (leakage >> unknown leakage type >> unknown location) gave an occurrence rate of 0.017% (complaints v sales).No negative trend in the number of complaints received has been identified.4111 communication/interviews: a/w additional information from site and scan review.

Event Description

Kink in a stent portion: a type a dissection was treated with total arch replacement (tar) and frozen elephant trunk (fet).The aorta was dissected in zone 2 and tar was performed.Implantation at the level of the peripheral aortic valve was assumed.The diameter of the peripheral true lumen was 22 to 23 mm.After anastomosis of the peripheral collar, anastomoses of the lsa, the peripheral part, and the branches were completed.The procedure was successfully completed as planned.On sunday, september 17, a stent portion was found to be kinked and tever was urgently performed.The exact position of the kink is unknown.A ctag stent-graft (gore) was implanted inside the stent, and the procedure was completed.Operation type: tar + fet for type a dissection.Blood loss: unknown.No image available.No additional information available.

Manufacturer Narrative

Manufacture's narrative clinical code: 4852 no clinical signs, symptoms or conditions: no health damage to the patient.Impact code: 2199 no health consequences or impact: no health damage to the patient.Medical device problem: 3190 insufficient information: a/w additional information from site and scan review.Component code: 4755 part/component/sub-assembly term not applicable: type of investigation: 4114 device not returned: device remains implanted.3331 analysis of production records: no issue found when batch review was performed.4109 historical data analysis: no issue found when batch review was performed.4110 trend analysis: a 5-year review of similar complaints (appearance/ product defect / curled / kinked / folds /twisted.) gave an occurrence rate of (b)(4) (complaints v sales).No negative trend in the number of complaints received has been identified.4111 communication/interviews: a/w additional information from site and scan review.Investigation findings : 213 - no device problem found - the device was manufactured to specification.Investigation conclusion: 4310 - cause traced to non-device related factors.- dicom imaging was not provided for review however screen recordings of pre and post op ct scans, intra operative imaging of the tevar reline and still images were provided and from the limited imaging available, it appears that a narrowing of the true lumen at the level of the aortic isthmus has prevented expansion of the first 2 proximal rings of the thoraflex hybrid stent section.An assessment of the device sizing cannot be made to determine oversize in the affected region.Ballooning and relining of the thoraflex hybrid device appears to have resolved the issue.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

Kink in a stent portion: a type a dissection was treated with total arch replacement (tar) and frozen elephant trunk (fet).The aorta was dissected in zone 2 and tar was performed.Implantation at the level of the peripheral aortic valve was assumed.The diameter of the peripheral true lumen was 22 to 23 mm.After anastomosis of the peripheral collar, anastomoses of the lsa, the peripheral part, and the branches were completed.The procedure was successfully completed as planned.On (b)(6), a stent portion was found to be kinked and tever was urgently performed.The exact position of the kink is unknown.A ctag stent-graft (gore) was implanted inside the stent, and the procedure was completed.Operation type: tar + fet for type a dissection, blood loss: unknown, no image available, no additional information available.This report is being submitted as follow up #1 for mfg.Report#: 9612515-2023-00025 to provide event closure information for (b)(4).

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID
• 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: 17955498
• MDR Text Key: 325901029
• Report Number: 9612515-2023-00025
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: THP3036X100J
• Device Lot Number: 25324287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2023
• 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: 50 YR
• Patient Sex: Male