MAUDE Adverse Event Report: VASCUTEK LTD; THORAFLEX HYBRID

Model Number THORAFLEX HYBRID

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2023

Event Type  Injury  

Event Description

A thoraflex hybrid (ref (b)(4), ns 2003232432, lot 25288113-5814) was implanted to treat a aortic dissection.The surgeon noticed that the prosthesis "oozed" a lot.The prosthesis had to be coated with coseal hemostatic glue to reduce bleeding.

Manufacturer Narrative

Manufacturers narrative (h6).Clinical code: 4580 insufficient information: lack of information provided by complainant.Impact code: 4643 blood transfusion: as stated on event intake form patient outcome was blood transfusion.4644 medication required: as stated on event intake form patient outcome novoseven was given to the patient.Medical device problem 3191 appropriate term/code not available: the surgeon noticed that the prosthesis "oozed" a lot.Component code 4755 part/component/sub-assembly term not applicable.Type of investigations 3331 analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4110 trend analysis: a 5-year review of similar complaints (leakage > blood oozing) gave an occurrence rate of (b)(4) (complaints v sales).There was an indication of an increasing trend requiring action at this time, capa impact assessment 221 was raised.4111 communication/interviews: additional information and scans/images has been requested.4114 device not returned: the device remains implanted.

Manufacturer Narrative

Manufacturers narrative (h6) clinical code: 4580 insufficient information: lack of information provided by complainant impact code: 4643 blood transfusion: as stated on event intake form patient outcome was blood transfusion 4644 medication required: as stated on event intake form patient outcome novoseven was given to the patient medical device problem 3191 appropriate term/code not available: the surgeon noticed that the prosthesis "oozed" a lot.Component code 4755 part/component/sub-assembly term not applicable.Type of investigations 3331 analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4110 trend analysis: a 5-year review of similar complaints (leakage > blood oozing) gave an occurrence rate of (b)(4) (complaints v sales).There was an indication of an increasing trend requiring action at this time, capa impact assessment 221 was raised.4111 communication/interviews: additional information received on 13th oct 23 confirmed that the graft was pre-soaked for 10-15 min 4114 device not returned: the device remains implanted.Investigation findings: 115 maintenance problem identified: additional information received on 13th oct 23 confirmed that the graft was presoaked for 10-15 min.In ifu 301-216 thoraflex hybrid gelita mdr section 15: it states thoraflex hybrid device must be immersed in saline solution (approximately 700ml) for 5 minutes.Investigation conclusion 18 failure to follow instructions: additional information received on 13th oct 23 confirmed that the graft was presoaked for 10-15 min.In ifu 301-216 thoraflex hybrid gelita mdr section 15: it states thoraflex hybrid device must be immersed in saline solution (approximately 700ml) for 5 minutes.

Event Description

A thoraflex hybrid ((b)(4) lot 25288113-5814) was implanted to treat a aortic dissection.The surgeon noticed that the prosthesis "oozed" a lot.The prosthesis had to be coated with coseal hemostatic glue to reduce bleeding.This report is being submitted as final for mfg report #9612515-2023-00024 to provide event closure information for (b)(4).

• 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: 17928673
• MDR Text Key: 325564694
• Report Number: 9612515-2023-00024
• 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: User Facility
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• 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: THP2830X100B-G
• Device Lot Number: 25288113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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: 52 YR
• Patient Sex: Male