MAUDE Adverse Event Report: VASCUTEK LTD; THORAFLEX HYBRID

Catalog Number THP2426X100J

Device Problem Insufficient Information (3190)

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

Event Date 09/08/2023

Event Type  Injury  

Event Description

The frozen elephant trunk device was attempted to be implanted to treat a distal aortic arch aneurysm.The artery was cut in zone 2 and the thoraflex hybrid was inserted.The stent graft section wasdeployed and the distal vessel was sutured to the collar.The aneurysm wall was anastomosed with the cuff.After branch vessels were reconstructed and the proximal vessel was anastomosed to the graft section, blood flow was resumed.Blood leakage was then observed from the collar sutures where the cuff reinforcing the distal vessel was anastomosed.Protamine was administered and act returned to normal.Hemostasis was achieved with hydrofit.Subsequently, the procedure was completed successfully.Operation type: total arch blood loss: amount unknown no image available no additional information available.This report has been submitted as initial/ final for mfg.Report fda.

Manufacturer Narrative

Manufacturers narrative section h6 clinical code 4582 no clinical signs, symptoms or conditions: there was no health damage to the patient impact code 2221 no health consequences or impact: there was no health damage to the patient medical device problem 3190 insufficient information: confirmation from the complainant on 22 sep 23, confirmed no additional information or images can be obtained from the complainant component code 4755 part/component/sub-assembly term not applicable: type of investigation 4109 historical data analysis: there was a full batch review was performed which showed no issues with product.4110 trend analysis: a 5-year review of similar complaints (leakage blood oozing) gave an occurrence rate of 0.030% (complaints v sales).No negative trend in the number of complaints received has been identified.3331 analysis of production records: there was a full batch review was performed which showed no issues with product 4114 device not returned: graft remains implanted.Investigation findings 3221 no findings available: due to insufficient information provide no root cause could be determined.Investigation conclusion 4315 cause not established: due to insufficient information provide no root cause could be determined.

• 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: 17902919
• MDR Text Key: 325247491
• Report Number: 9612515-2023-00020
• 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
• Report Date: 10/10/2023

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: THP2426X100J
• Device Lot Number: 25324185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2023
• 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: 65 YR
• Patient Sex: Male