MAUDE Adverse Event Report: VASCUTEK LTD; THORAFLEX HYBRID

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

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

Event Date 10/03/2023

Event Type  Injury  

Event Description

Blood leakage: blood leakage occurred from the factory anastomosis between the vascular graft section and the stented graft section.Hemostatic agent was applied to achieve hemostasis and the procedure was successfully completed.No health damage to the patient.Operation type: total arch replacement.Blood loss: unknown.No image available.No additional information available.This report is being submitted as final for mfg report #9612515-2023-00031 to provide event closure information for comp (b)(4).

Manufacturer Narrative

Manufacture's narrative.Clinical code.4582-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: the site confirmed on 01 nov 23 that no further information would be obtained.Component code.4755-part/component/sub-assembly term not applicable.Type of investigation.4119- insufficient information: the site confirmed on 01 nov 23 that no further information would be obtained.4114-device not returned: device remains implanted.4110- trend analysis: a 5-year review of similar complaints (leakage > blood oozing) gave an occurrence rate of (b)(4) (complaints v sales).Investigation findings.3221- no findings available: due to insufficient information being provided from the site further investigation could not be carried out.Investigation conclusion.4315- cause not established: due to insufficient information being provided from the site further investigation could not be carried out.

• 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: 18169588
• MDR Text Key: 328533126
• Report Number: 9612515-2023-00031
• 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: 11/20/2023

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 Model Number: UNKNOWN
• Device Catalogue Number: THP3034X100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/20/2023
• 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