MAUDE Adverse Event Report: VASCUTEK LTD.; THORAFLEX HYBRID

Catalog Number THP3032X100B

Device Problem Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/29/2023

Event Type  Injury  

Event Description

Event description: on (b)(6) 2023, the patient presented spontaneously to the hospital with aphasic disorders such as a lack of words that had suddenly appeared since 8 p.M.After consultation with the cardiac surgeon, confirmation that the neurological symptoms presented are probably related to the occlusion of the left common carotid arterial branch already present on the scanner 10 days ago but not on the previous post-op scanners, indication to a carotid-under left subclavian artery bypass.No information if event is device related, procedure related or patient pre-condition related.Doctor prescribed additional explorations: a doppler of the supra-aortic trunks, an angioscanner of the asd and of the skull as well as a cerebral mri as well as kardégic 75 mg to be taken daily.

Manufacturer Narrative

Clinical code: 2422 obstruction/occlusion: the patient presented spontaneously to the hospital with aphasic disorders such as a lack of words that had suddenly appeared since 8 p.M.After consultation with the cardiac surgeon, confirmation that the neurological symptoms presented are probably related to the occlusion of the left common carotid arterial branch already present on the scanner 10 days ago but not on the previous post-op scanners, indication to a carotid-under left subclavian artery bypass.Impact code: 4641 unexpected medical intervention: patient is prescribed additional explorations: a doppler of the supra-aortic trunks, an angio scanner of the asd and of the skull as well as a cerebral mri as well as kardégic 75 mg to be taken daily.Medical device problem: 3190 insufficient information: no information if event is device related, procedure related, or patient pre-condition related.Type of investigation: 4110 trend analysis: a 5 year similar events review occlusion/ thrombosis (artery) gave and occurrence rate of 0.058%.No negative trend was identified.3331 analysis on production records: a review of the manufacturing and qc records confirm that device was manufactured to specification.4114 device not returned: device remains implanted.

Event Description

Event description: on (b)(6) 2023, the patient presented spontaneously to the hospital with aphasic disorders such as a lack of words that had suddenly appeared since 8 p.M.After consultation with the cardiac surgeon, confirmation that the neurological symptoms presented are probably related to the occlusion of the left common carotid arterial branch already present on the scanner 10 days ago but not on the previous post-op scanners, indication to a carotid-under left subclavian artery bypass.No information if event is device related, procedure related or patient pre-condition related.Doctor prescribed additional explorations: a doppler of the supra-aortic trunks, an angioscanner of the asd and of the skull as well as a cerebral mri as well as kardégic 75 mg to be taken daily.This report is being sent to provide complaint closure information for mfg report #9612515-2023-00008 ( comp (b)(4)).

Manufacturer Narrative

H6 - additional information.Clinical code: 2422 obstruction/occlusion: the patient presented spontaneously to the hospital with aphasic disorders such as a lack of words that had suddenly appeared since 8 p.M.After consultation with the cardiac surgeon, confirmation that the neurological symptoms presented are probably related to the occlusion of the left common carotid arterial branch already present on the scanner 10 days ago but not on the previous post-op scanners, indication to a carotid-under left subclavian artery bypass.Impact code: 4641 unexpected medical intervention: patient is prescribed additional explorations: a doppler of the supra-aortic trunks, an angio scanner of the asd and of the skull as well as a cerebral mri as well as kardégic 75 mg to be taken daily.Component code: 4755 part/ component/ sub-assembly term not applicable.Medical device problem: 3190 insufficient information: no information if event is device related, procedure related, or patient pre-condition related.Type of investigation: 4110 trend analysis: a 5 year similar events review occlusion/ thrombosis (artery) gave and occurrence rate of 0.058%.No negative trend was identified.3331 analysis on production records: a review of the manufacturing and qc records confirm that device was manufactured to specification 4114 device not returned: device remains implanted.Investigation findings 3221 - no findings available - further information from the site received on 24 aug 23 the site has spoken to the clinician who had confirmed that reported events were possibly device related as the physician do not see any procedural or anatomical reason for the thrombosis event: not confirmed.Investigation conclusion 4315 - cause not established- further information from the site received on 24 aug 23 the site has spoken to the clinician who had confirmed that reported events were possibly device related as the physician do not see any procedural or anatomical reason for the thrombosis event: not confirmed.

• 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: 17478436
• MDR Text Key: 320569302
• Report Number: 9612515-2023-00008
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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 Expiration Date: 09/30/2022
• Device Catalogue Number: THP3032X100B
• Device Lot Number: 21559854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 09/07/2023
• 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): Other
• Patient Age: 45 YR
• Patient Sex: Male