MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID

Catalog Number THP3036X100J

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturers narrative.Clinical code: 4582 - no clinical signs, symptoms or conditions: no harm to the patient's health.Impact code: 2199 - no health consequences or impact: no harm to the patient's health.Medical device problem 3191 - appropriate term/code not available: , slight blood leakage occurred from the factory sutures of the product.Hydrofit was used to stop the blood leakage.Component code.4755 - part/component/sub-assembly term not applicable: type of investigation.4110 - trend analysis: a 5 year review of similar complaints (thoraflex hybrid jan 19 to feb 24 vs nature of event: leakage from factory suture) gave an occurrence rate of (b)(4)% (complaints v sales).4111 - communication/interview's: information received from site on 14 feb 24 & 21 feb 24, no defect in appearance were noted.Graft was pre-soaked prior to use and the user believes that the device feature, combination of woven surgical graft and stent graft, caused this event.3331 - analysis of production record: full batch review was performed from raw material to finished product, that confirmed there were no issues with the device during manufacturing.4114 - device not returned: device remains implanted.

Event Description

Blood leakage: the thoraflex stented graft section was deployed and the collar was sutured to the distal vessel.After suturing was completed, slight blood leakage occurred from the factory sutures of the product.Hydrofit was used to stop the blood leakage.Subsequently, the procedure was completed successfully.Blood leakage from the factory stitched area operation type: total arch replacement possibly device failure/ deficiency/ procedure/ pre-existing condition patient outcome: no harm to the patient's health.

Event Description

Blood leakage: the thoraflex stented graft section was deployed and the collar was sutured to the distal vessel.After suturing was completed, slight blood leakage occurred from the factory sutures of the product.Hydrofit was used to stop the blood leakage.Subsequently, the procedure was completed successfully.Blood leakage from the factory stitched area operation type: total arch replacement possibly device failure/deficiency/procedure/pre-existing condition patient outcome: no harm to the patient's health.This report is being submitted as a final follow up 1 for manufacturing report #9612515-2024-00013 to provide event closure information for (b)(4).

Manufacturer Narrative

Manufacturers narrative clinical code: 4582 - no clinical signs, symptoms or conditions: no harm to the patient's health.Impact code: 4630 - modified surgical procedure - hydrofit was used to stop the blood leakage.Medical device problem 2993 - adverse event without identified device or use problem: , slight blood leakage occurred from the factory sutures of the product.Hydrofit was used to stop the blood leakage.Site confirmed that there was no device problem.Component code 4755 - part/component/sub-assembly term not applicable: type of investigation 4110 - trend analysis: a 5 year review of similar complaints (thoraflex hybrid jan 19 to feb 24 vs nature of event: leakage from factory suture) gave an occurrence rate of 0.043% (complaints v sales).4111 - communication/interview's: information received from site on 14 feb 24 & 21 feb 24, no defect in appearance were noted.Graft was pre-soaked prior to use and the user believes that the device feature, combination of woven surgical graft and stent graft, caused this event.3331 - analysis of production record: full batch review was performed from raw material to finished product, that confirmed there were no issues with the device during manufacturing 4117 - device not accessable for testing: device remains implanted investigation findings: 213 - no device problem found - the site confirmed there was no defects with the device.This type of device is likley to bleed slightly at the join during implantation because it is a hand sewn anastomosis.The benchtop testing has identified the current levels of bleeding as acceptable.Investigation conclusions: 22 - known inherent risk of device - the site confirmed no defects with the device.This type of device is likley to bleed slightly at the join during implantation because it is a hand sewn anastomosis.The benchtop testing has identified the current levels of bleeding as acceptable.67 - no problem detected - slight blood leakage occurred from the factory sutures of the product.Hydrofit was used to stop the blood leakage.Site confirmed that there was no device problem.

• 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; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 18874488
• MDR Text Key: 337318015
• Report Number: 9612515-2024-00013
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P210006
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: THP3036X100J
• Device Lot Number: 25324283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2023
• 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 Sex: Female