MAUDE Adverse Event Report: VASCUTEK LTD.; THORAFLEX HYBRID

Catalog Number THP2830X100J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/15/2023

Event Type  Injury  

Manufacturer Narrative

H6 manufacturere narrative: clinical code: 4582 no heath damage to patient.Impact code 2199 no health damage to patient.Medical device problem code: 2993 adverse event with without identified device or use problem - leakage was noted and reported as possibly related to the device , procedure and pre existing condition, however graft remains in situ and no pre / post op imaging has been supplied so no further investigation is possible for this event.Component code 4755 no sub-assemblies or component parts.Type of investigation: 4109 historical data analysis: batch review performed which showed no issues.4110 trend analysis: a 5-year review of similar complaints (leakage , hole / pinhole , body).Gave an occurrence rate of 0.009%.3331 analysis of production records: a review of manufacturing and qc records.Confirmed that there were no issues with the manufacture of the device.4114 device not returned: device remains implanted.4117 device not accessible for testing: device remains implanted.Investigation findings 3221 no findings available: leakage was reported, however no ct scans, no additional information was provided, and graft remains implanted therefore no further investigation is possible.Investigation conclusion 4315 cause not established: leakage was reported, however no ct scans, no additional information was provided, and graft remains implanted therefore no further investigation is possible.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

As as per reporter's narrative: blood leakage from needle holes on the stitched area of the collar and the graft (stitched during manufacturing).When the anastomosis of the arch branch was completed using frozen elephant trunk technique and the surgery was almost in its final stage, blood oozing was noted from the entire stitched area of the collar and the graft (needle holes stitched during manufacturing).Hydrofit was therefore used for hemostasis, which was successfully achieved.No health damage to the patient.Manufacturer's understanding: device related: possibly / procedure related: possibly / pre-existing condition: possibly / surgical intervention: no potential failure mode: leakage > hole / pinhole > body this report is being submitted to provide initial / final information for closure of mfg report.(b)(4).

• 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: 17697426
• MDR Text Key: 322801513
• Report Number: 9612515-2023-00018
• 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: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• 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: 25324238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Female