MAUDE Adverse Event Report: VASCUTEK LTD; THORAFLEX HYBRID

Catalog Number THP2426X100J

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/15/2023

Event Type  Injury  

Event Description

Endoleak type 1b, on (b)(6), a ct scan revealed endoleak type 1b or dsine suspected.On (b)(6), an additional tevar was performed distally for placement of a stent-graft (valiant,medtronic).Leakage from the distal portion of the previously implanted thoraflex hybrid was resolved.Subsequently, the procedure was completed successfully.No health damage to the patient.

Manufacturer Narrative

Manufacturers 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 code: 3191 appropriate term/code not available: leakage (endoleak type 1).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: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4111 communication/interviews: additional information and pre/post op scans was requested.4110 trend analysis: a 5-year review of similar complaints (endo leak type 1) gave an occurrence rate of (b)(4) (complaints v sales).No negative trend in the number of complaints received has been identified.4109 historical data analysis: full batch review performed which showed no issues with product or raw materials.

Manufacturer Narrative

Manufacturers 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 code : 3191appropriate term/code not available: leakage (endoleak type 1).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: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4111 communication/interviews: additional information and pre/post op scans was requested.4110 trend analysis: a 5-year review of similar complaints (endo leak type 1) gave an occurrence rate of (b)(4) (complaints v sales).No negative trend in the number of complaints received has been identified.4109 historical data analysis: full batch review performed which showed no issues with product or raw materials.Investigation findings: 4247 appropriate term/code not available: site confirmed on 18 oct 23that no further information will be obtained for this event.Investigation conclusion: 4315 cause not established: due to a lack of information or return of the device the root cause of this event could not be determined.Correction to date report sent from 10/01/2023 to 11/01/2023.

Event Description

Endoleak type 1b, on september 15, a ct scan revealed endoleak type 1b or dsine suspected.On september 19, an additional tevar was performed distally for placement of a stent-graft (valiant,medtronic).Leakage from the distal portion of the previously implanted thoraflex hybrid was resolved.Subsequently, theprocedure was completed successfully.No health damage to the patient.Tis report is being submitted aa final for mfg.Report # 9612515-2023-00026 to provide event closure information for (b)(4).

Event Description

Endoleak type 1b, on (b)(6), a ct scan revealed endoleak type 1b or dsine suspected.On september 19, an additional tevar was performed distally for placement of a stent-graft (valiant,medtronic).Leakage from the distal portion of the previously implanted thoraflex hybrid was resolved.Subsequently, theprocedure was completed successfully.No health damage to the patient.Tis report is being submitted aa final for mfg.Report # 9612515-2023-00026 to provide event closure information for comp 5137.

Manufacturer Narrative

Manufacturers 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 code 3191appropriate term/code not available: leakage (endoleak type 1) 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: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device 4111 communication/interviews: additional information and pre/post op scans was requested 4110 trend analysis: a 5-year review of similar complaints (endo leak type 1) gave an occurrence rate of 0.068% (complaints v sales).No negative trend in the number of complaints received has been identified 4109 historical data analysis: full batch review performed which showed no issues with product or raw materials.Investigation findings 4247 appropriate term/code not available: site confirmed on 18 oct 23that no further information will be obtained for this event.Investigation conclusion 4315 cause not established: due to a lack of information or return of the device the root cause of this event could not 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: 17955554
• MDR Text Key: 325899482
• Report Number: 9612515-2023-00026
• 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,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• 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
• 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