MAUDE Adverse Event Report: VASCUTEK LTD; THORAFLEX HYBRID

Catalog Number THP2830X100J

Device Problem Defective Device (2588)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/25/2023

Event Type  Injury  

Event Description

Kink in a stent graft section: on (b)(6), 2023, the thoraflex hybrid was used in an emergency procedure, and the procedure was successfully completed without any problems after confirmation with ct at 2:00 am on (b)(6).In the early in the morning of (b)(6), as the blood pressure in the leg dropped to 60mmhg, the ct was performed again, and the stent graft section appeared to be kinked.An emergency tever was performed, and a stent-graft was additionally implanted inside the thoraflex hybrid.The blood pressure in the leg recovered to 100 mmhg after implantation.The tc representative will see the physician on (b)(6) to obtain further information.The patient was in a serious condition but recovered.

Manufacturer Narrative

Manufactures narrative: clinical code: 4581-appropriate clinical signs, symptoms, conditions term / code not available: the patient was in a serious condition but recovered.Impact code: 4625- additional surgery: an emergency tever was performed, and a stent-graft was additionally implanted inside the thoraflex hybrid.The blood pressure in the leg recovered to 100 mmhg after implantation.Medical device problem: 2588-defective device: the stent graft section appeared to be kinked.The additional information currently from the site is: the device size was measured based on the false lumen plus the true lumen diameter, which may have been oversized against the true lumen diameter.The device may have been compressed by the distal false lumen.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: full batch review was performed, and no issues were found with manufacturing / qc record or raw materials.4111-communication/interviews: additional information requested & received on 25 sep 2023, also scans were requested a/w update from site.4110-trend analysis: a 5-year review of similar complaints (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.

Event Description

Kink in a stent graft section: on (b)(6) 2023, the thoraflex hybrid was used in an emergency procedure, and the procedure was successfully completed without any problems after confirmation with ct at 2:00 am on september 25.In the early in the morning of september 25, as the blood pressure in the leg dropped to 60mmhg, the ct was performed again, and the stent graft section appeared to be kinked.An emergency tever was performed, and a stent-graft was additionally implanted inside the thoraflex hybrid.The blood pressure in the leg recovered to 100 mmhg after implantation.The tc representative will see the physician on september 26th to obtain further information.The patient was in a serious condition but recovered.This report has been submitted as a final for mfg.Report fda 9612515-2023-00027 to provide correction to device details.

Manufacturer Narrative

Manufactures narrative: clinical code: 4581-appropriate clinical signs, symptoms, conditions term / code not available: the patient was in a serious condition but recovered.Impact code: 4625- additional surgery: an emergency tever was performed, and a stent-graft was additionally implanted inside the thoraflex hybrid.The blood pressure in the leg recovered to 100 mmhg after implantation.Medical device problem: 2588-defective device: the stent graft section appeared to be kinked.The additional information currently from the site is: the device size was measured based on the false lumen plus the true lumen diameter, which may have been oversized against the true lumen diameter.The device may have been compressed by the distal false lumen.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: full batch review was performed, and no issues were found with manufacturing / qc record or raw materials.4111-communication/interviewsthe site confirmed that the graft was kinked: the physician says there was multiple factors that may have cause the kink; the device size was measured based on the false lumen plus the true lumen diameter, which may have been oversized against the true lumen diameter.The device may have been compressed by the distal false lumen.During the procedure, the stent opening was also checked by transesophageal echocardiography and appeared to be no issues.It was difficult to confirm as the arch section is difficult to see and there was no problem with the graft during implantation.Tevar was performed and the patient's condition appeared to stable after this was performed.The physician considers that it cannot be determined the patient outcome was reported as patient recovered.4110-trend analysis: a 5-year review of similar complaints (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.Investigation findings: 3221- no findings available: due to all additional information not being provided, this investigation could not be completed.Investigation conclusion: 4315- cause not established: due to all additional information not being provided, this investigation could not be completed.

• 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: 17993582
• MDR Text Key: 326350459
• Report Number: 9612515-2023-00027
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: THP2830X100J
• Device Lot Number: 25324226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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