MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD HEMABRIDGE WOVEN; VASCULAR POLYESTER GRAFT

Model Number HEW3010BRIDGE

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 04/21/2019

Event Type  Death  

Manufacturer Narrative

A review of the complaint device history records is ongoing, results are pending.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

During a total arch replacement and tevar procedure, the surgeon connected the involved graft with a 3-branch hemashield graft, and the operation was completed.After angiostomy, bleeding was identified on the proximal part of the graft where a needle puncture was performed for deairing.At the completion of this first operation, small bleeding was observed but the surgeon thought it would stop and closed the patient's chest.However, the patient's condition was not good, and a second operation was performed.On the second exploration, bleeding occurred in the area where the two grafts were connected.Various hemostatic agents, like flosea and surgical berilast, were applied, which reduced the bleeding amount.About x20 pledgeted reinforcement interrupted sutures were placed on the blood oozing surface of the graft, and finally bleeding stopped.Blood transfusion and hemostatic pledget repair were performed for 2.5 hours.However, a few hours later, the patient had a heart arrest.Ecmo was performed but the patient died in a week (exact date of death is unknown).Additional information: transfusion : rbc 320cc 30ea, ffp 40cc 16ea.The patient had no bleeding tendency before the operation.

Manufacturer Narrative

Expiration has been corrected.(4117) device is not accessible for testing as it remained implanted in the patient.(3331/213) a review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Moreover, the review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications (< 5 ml/cm²/min).(4109/213) the review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.(4315) no conclusion can be drawn since the product remained implanted.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.The case has been reviewed by our corporate medical officer, his assessment is as follows: "it is difficult to speculate on the possible causes of the bleeding.It is however very uncommon for volume and area of interest.It could be assumed that due to the needle insertion and the subsequent closure the area surrounding the hole was subjected to additional stretch and trauma.Therefore, the collagen coating could have been disrupted causing the diffuse bleeding.However this remains speculation as in absence the specimen for analysis it is impossible to draw a conclusive assessment of the causes of the event.".

• Brand Name: INTERGARD HEMABRIDGE WOVEN
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8649086
• MDR Text Key: 146333632
• Report Number: 1640201-2019-00030
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401001027
• UDI-Public: 00384401001027
• Combination Product (y/n): N
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2022
• Device Model Number: HEW3010BRIDGE
• Device Catalogue Number: HEW3010BRIDGE
• Device Lot Number: 17F01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 63