MAUDE Adverse Event Report: VASCUTEK LTD; THORAFLEX HYBRID

Catalog Number	THA3032X150A-G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician noticed that the grafts was pulsing blood at the anastomosis of the stent and surgical graft.He says that it appears to be coming from the green suture line that connects the stent, graft and skirt.He chose to leave the patient open' overnight to see if it would resolve on its own and it did.He was concerned with the bleeding as he never had this occur before with this device.He has implants 6-7 thoraflex so far and has not experienced this.The clinician reporting this occurrence to see if this can be investigated to see if a root cause can be identified and corrected.
Additional Manufacturer Narrative
Clinical code: 4580 - insufficient information: additional information has been requested from site.Impact code: 4648- insufficient information: additional information has been requested from site.Medical device problem: 3190- insufficient information: additional information has been requested from site.Component code: 4755 -part/component/sub-assembly term not applicable.Type of investigation: 4110- trend analysis: a 5-year review of similar complaints (leakage blood oozing) gave an occurrence rate of 0.051% (complaints v sales).An increasing trend has been identified at this time, capa impact assessment 221 is currently ongoing.3331- analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4114- device not returned: device remains implanted.4111- communication/interviews: additional information has been requested from site.
Additional Manufacturer Narrative
Clinical code: clinical code: 4580 - insufficient information: additional information from site conformed the patient required open chest due to excessive bleeding from the suture line with packing of the mediastinum and return to or 24 hours later for definitive chest closure.Impact code: 4648- insufficient information: additional information from site conformed the patient required open chest due to excessive bleeding from the suture line with packing of the mediastinum and return to or 24 hours later for definitive chest closure.Medical device problem: 3190- insufficient information: additional information was received on 22 nov 23 from site that confirmed the graft was not pre-soaked prior to use.In the thoraflex hybrid us ifu (301-213-usen) it states to soak the graft for 5 minutes on approximately 700ml of saline solution.Component code: 4755 -part/component/sub-assembly term not applicable.Type of investigation: 4110- trend analysis: (b)(4).An increasing trend has been identified at this time, capa impact assessment 221 is currently ongoing.3331- analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4114- device not returned: device remains implanted.4111- communication/interviews: additional information was received on 22 nov 23 from site that confirmed the graft was not pre-soaked prior to use.In the thoraflex hybrid us ifu (301-213-usen) it states to soak the graft for 5 minutes on approximately 700ml of saline solution.Investigation findings: 115-maintenance problem identified: : additional information was received on 22 nov 23 from site that confirmed the graft was not pre-soaked prior to use.In the thoraflex hybrid us ifu (301-213-usen) it states to soak the graft for 5 minutes on approximately 700ml of saline solution.Investigation conclusion: 18- failure to follow instructions: additional information was received on 22 nov 23 from site that confirmed the graft was not pre-soaked prior to use.In the thoraflex hybrid us ifu (301-213-usen) it states to soak the graft for 5 minutes on approximately 700ml of saline solution.
Event or Problem Description
The clinician noticed that the grafts was pulsing blood at the anastomosis of the stent and surgical graft.He says that it appears to be coming from the green suture line that connects the stent, graft and skirt.He chose to leave the patient [?]open' overnight to see if it would resolve on its own and it did.He was concerned with the bleeding as he never had this occur before with this device.He has implants 6-7 thoraflex so far and has not experienced this.The clinician reporting this occurrence to see if this can be investigated to see if a root cause can be identified and corrected.Additional information was received on 22 nov 23 from site that confirmed the graft was not pre-soaked prior to use.In the thoraflex hybrid us ifu (301-213-usen) it state [?]s to soak the graft for 5 minutes on approximately 700ml of saline solution this report is being submitted as final for mfg report #9612515-2023-00028 to provide event closure information for comp (b)(4).

• Common Device Name: 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: 18047893
• Report Number: 9612515-2023-00028
• Device Sequence Number: 8026291
• Product Code: QSK
• UDI-Device Identifier: 05037881027036
• UDI-Public: 05037881027036
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: THA3032X150A-G
• Device Lot Number: 25194661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male