MAUDE Adverse Event Report: VASCUTEK LTD; THORAFELX HYBRID

Catalog Number THP2628X100J

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturers narrative: clinical code: 4580 insufficient information: additional information has been requested for this event, a/w customer feedback.Health effect: 4648 insufficient information: additional information has been requested for this event, a/w customer feedback.Medical device problem: 3190 insufficient information: additional information has been requested for this event, a/w customer feedback.Component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 4110 trend analysis: a 5-year review of similar complaints (occlusion/thrombosis > emboli/stenosis) gave an occurrence rate of 0.016% (complaints v sales).No negative trend in the number of complaints received has been identified.3331 analysis of production records: full batch review has been performed which showed no issues from finished product to raw material.4111 communication/interviews: additional information has been requested for this event, a/w customer feedback.4114 device not returned: device remains implanted.

Event Description

Implantation of the thoraflex hybrid was successfully completed, but post-operative ct showed stenosis at the second to the third stents from the tip of the stent graft section along the patient's aortic curvature.The difference in blood pressure between the upper limbs and the lower limbs was measured and no difference was found.However, due to concerns that blood flow to the lower limbs may be blocked, tevar is scheduled on (b)(6).The ct data will be provided later.Operation type: aortic arch replacement with osg.

Manufacturer Narrative

Manufacturers narrative.Clinical code: 4580 insufficient information: additional information was received on 15 nov 23.The patient outcome was: the patient recovered without any particular problems.Health effect: 4648 insufficient information: additional information was received on 15 nov 23.The patient outcome was: the patient recovered without any particular problems medical device problem: 3190 insufficient information: on (b)(6) 2023, an additional tevar was performed using a relaypro nbs.Component code: 4755 part/component/sub-assembly term not applicable.Type of investigation 4110 trend analysis: a 5-year review of similar complaints (occlusion/thrombosis > emboli/stenosis) gave an occurrence rate of 0.016% (complaints v sales).No negative trend in the number of complaints received has been identified.3331 analysis of production records: full batch review has been performed which showed no issues from finished product to raw material.4111 communication/interviews: additional information was received on 15 nov 23.There was no artery calcified or any particulate/visible on the outer or inner surfaces of the graft during implant.The graft was cut using an electric cautery, there was graft manipulation as the fenestration was performed.The patient outcome was: the patient recovered without any particular problems.Investigation findings 3221 no findings available: the root cause for this event not determined, this was due to the device not being returned or pre/post op scans being made available for review.Full batch review was performed which show no issue with raw material or finished product.Investigation conclusion 4315 cause not established: the root cause for this event not determined, this was due to the device not being returned or pre/post op scans being made available for review.Full batch review was performed which show no issue with raw material or finished product.

Event Description

Implantation of the thoraflex hybrid was successfully completed, but post-operative ct showed stenosis at the second to the third stents from the tip of the stent graft section along the patient's aortic curvature.The difference in blood pressure between the upper limbs and the lower limbs was measured and no difference was found.However, due to concerns that blood flow to the lower limbs may be blocked, tevar is scheduled on (b)(6).The ct data will be provided later.Operation type: aortic arch replacement with osg.Additional information about the event was requested on 17 oct 2023.Additional information was received on 15 nov 2023.There was no artery calcified or any particulate/visible on the outer or inner surfaces of the graft during implant the graft was cut using an electric cautery, there was graft manipulation as the fenestration was performed.The patient outcome was: the patient recovered without any particular problems.This report is being submitted as final for mfg report #9612515-2023-00030 to provide event closure information forcomp 5159.

• Type of Device: THORAFELX HYBRID
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• 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; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 18129333
• MDR Text Key: 327994991
• Report Number: 9612515-2023-00030
• 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
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: THP2628X100J
• Device Lot Number: 25326193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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