MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID; THORAFLEX HYBRID PLEXUS

Model Number THORAFLEX HYBRID PLEXUS

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Event reported on (b)(6) 2022 from thor study, thoraflex hybrid plexus device implanted on (b)(6) 2019.Abscess in the area aortic ascendants and aortic root, distal in hybrid prothesis, date of event unknown.Reported as possibly device related and possibly related to procedure.

Manufacturer Narrative

Manufacturer narrative : section h6 investigation findings : 213 - no device problem found - no issue has been found upon review of the retained device history records and sterilization records for this device.Endotoxin and bioburden results for the period of manufacture were also reviewed which showed the device was manufactured and sterilized to specification.Investigation conclusion: 4315 - cause not established - device showed infection after 2 months - candida glabrata and candida albicans were both isolated.Candida is a genus of yeasts that live naturally in and on the body.Tag products are sterilised using 100% ethylene oxide which is a bactericidal chemical.The sterilisation process is fully validated ensuring a sterility assurance level (sal) of 10-6 using bacillus atrophaeus biological indicators.C.Glabrata and c.Albicans do not present with a significant resistance to the sterilisation process when compared to the biological indictor organism and would therefore not survive the process if present.As no issues with the sterile barrier packaging was reported to us, this would indicate that when the graft was opened from its protective packaging, it was sterile.Therefore; it can be assumed that the more likely source of that type of organism is personnel or cross contamination of equipment; however this cannot be confirmed by vascutek ltd.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

This report is being submitted as follow up#1 for mfg report#9612515-2022-00027 to provide event closure information for comp (b)(4).

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID PLEXUS
• 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: 16032167
• MDR Text Key: 305974682
• Report Number: 9612515-2022-00027
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/30/2020
• Device Model Number: THORAFLEX HYBRID PLEXUS
• Device Catalogue Number: THP3040X150B
• Device Lot Number: 17376337
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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: 79 YR
• Patient Sex: Male