MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID

Model Number THORAFLEX HYBRID

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

Patient Problem Unspecified Infection (1930)

Event Date 08/29/2023

Event Type  Injury  

Event Description

Patient had type b disecssion with bental in the past the observation of the condition of the patient after fet by using thoraflex is the fever that cannot stop.The doctor described that after surgery patient got a fever and he monitored to cut the fever with antibiotic but it is still happening and he still investing the reason.

Manufacturer Narrative

Manufacturers narrative; section h6; clinical code: 1930 - unspecified infection reported.Impact code: 4641 - unexpected medical intervention , patient has been given antibiotics.4624 - unexpected surgical intervention , graft was explanted.4648 - insufficient information - further information has been requested from the site.Medical device problem 2993 - adverse event without identified device or use problem,- further information has been requested from the site.Component code 4755 part/component/sub-assembly term not applicable: type of investigation 4109 historical data analysis: no negative trend in the number of complaints received has been identified.4110 trend analysis: a 5-year review of similar complaints (thoraflex hybrid / medical event ( fever) ) gave an occurrence rate of 0.008% (complaints v sales).3331 analysis of production records: sterilization records review and a full batch review was performed which showed no issues with product.Review of the ifu mentions that infection is a potential adverse event.4114 device not returned: device is no longer available to be returned to tag for investigation.

Manufacturer Narrative

Manufacturers narrative: section h6: clinical code: 1930 - unspecified infection reported.Impact code: 4641 - unexpected medical intervention , patient has been given antibiotics.4624 - unexpected surgical intervention , graft was explanted.4648 - insufficient information - no further information provided from site.Due to this the complaint will be closed.2993 - adverse event without identified device or use problem,-no further information provided from site.Due to this the complaint will be closed.Component code: 4755 part/component/sub-assembly term not applicable: type of investigation: 4109 historical data analysis: no negative trend in the number of complaints received has been identified.4110 trend analysis: (b)(4) (complaints v sales).3331 analysis of production records: sterilization records review and a full batch review was performed which showed no issues with product.Review of the ifu mentions that infection is a potential adverse event.4114 device not returned: device is no longer available to be returned to tag for investigation.Investigation conclusion : 3221- no findings available: no further information provided from site.Due to this the complaint will be closed.Investigation conclusion: 4315- cause not established: no further information provided from site.Due to this the complaint will be closed.

Event Description

Patient had type b disecssion with bental in the past the observation of the condition of the patient after fet by using thoraflex is the fever that cannot stop.The doctor described that after surgery patient got a fever and he monitored to cut the fever with antibiotic but it is still happening and he still investing the reason.Full batch review was performed which showed no issues with the finished product or raw materials.No further information provided from complainant, due to this the complaint will be closed this report is being submitted as final for mfg report #9612515-2023-00021 to provide event closure information for(b)(4).

• Brand Name: THORAFLEX HYBRID
• 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 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: 17903392
• MDR Text Key: 325250256
• Report Number: 9612515-2023-00021
• Device Sequence Number: 1
• Product Code: QSK
• UDI-Device Identifier: 00537881031736
• UDI-Public: 0537881031736
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: P21006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: THORAFLEX HYBRID
• Device Catalogue Number: THP2628X100B
• Device Lot Number: 25239302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• 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): Other
• Patient Age: 27 YR
• Patient Sex: Male