MAUDE Adverse Event Report: VASCUTEK LTD; THORAFLEX HYBRID

Catalog Number THP3034X100B

Device Problem Insufficient Information (3190)

Patient Problem Embolism/Embolus (4438)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

Clinical code: 4438 embolism / embolus: ct revealed an embolus of the left common femoral artery and a right common femoral artery pseudoaneurysm.Impact code: 4624 surgical intervention: left common femoral artery embolectomy and right common femoral artery pseudoaneurysm was repaired.4641 unexpected medical intervention: patient was started on iv heparin and taken to or by vascular surgery for surgical intervention.Medical device problem code: 3190 insufficient information: a/w batch details to be provided from complainant.Component code 4756 appropriate term/ code not available.Type of investigation: (b)(4).Investigation findings: 213 - no device problem found: site confirmed on 23 aug 2023 that this event ws not device related.Investigation conclusion: 4310 - caused trace to non-device related factors: site confirmed on 23 aug 2023 that this event ws not device related.

Event Description

As per reporter's narrative: thor study.Clinical trial thor_torontogeneral patient number (b)(6), a female patient of 77 years old had relevant medical condition of thoracic aneurysm, coronary artery disease, copd, diabetes (type unknown), history of stroke and taking antiplatelets (asa81) prior to procedure.Former smoker and asa grade 4.The events were related to the device failure/ deficiency but not related to procedure or pre-existing condition and surgical intervention was required.On the post-operative day 6/7, patient developed left lower extremity coolness, pain and tingling and loss of left dorsalis pedalis/posterior tibialis pulses.Ct revealed an embolus of the left common femoral artery and a right common femoral artery pseudoaneurysm.Patient was started on iv heparin and taken to or by vascular surgery for surgical intervention.Left common femoral artery embolectomy and right common femoral artery pseudoaneurysm was repaired.Additional information received from site on 23 aug 23 confirmed this event was not device related.Site also confirmed unfortunately they are unable to provide batch details for this event.This report has been submitted as initial/ final for mfg.Report fda 9612515-2023-00013.

• 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: 17609856
• MDR Text Key: 321803789
• Report Number: 9612515-2023-00019
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: THP3034X100B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 77 YR
• Patient Sex: Female