MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC EXXCEL SOFT EPTFE VASCULAR GRAFTS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number VS004830580

Device Problems Leak/Splash (1354); Obstruction of Flow (2423)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported exxcel soft eptfe vascular graft blood leakage was confirmed from graft transplanted in the past.The transplanted graft was removed, and the graft was newly transplanted by reoperation.

Manufacturer Narrative

Corrected sections: b1 - changed to adverse event and product problem.H1 - changed to serious injury.H6 patient code - changed to no consequence or impact to patient; h6 device code - changed to obstruction of flow.Trackwise # (b)(4).The graft was returned to the factory for evaluation on 8/14/2019.An evaluation was conducted on 5/18/2020.Signs of clinical use and evidence of blood was observed.The graft was cut at an angle and the sutures were still present on the graph.Few of the support rings near the suturing site were cut.The cuts were clean indicating that the cuts may have been made in an effort to remove the graft from the implant site.Signs of blood clot were observed on the outside layer of the graft.Based on the returned condition of the device and evaluation results, the reported failure for "obstruction of flow" was confirmed.The exxcel soft vascular graft is approved for repair or replacement of peripheral arteries and vascular access procedures.It is also contraindicated for coronary bypass because of the high likelihood of occlusion.

Event Description

Hospital reported exxcel soft eptfe vascular graft occlusion was confirmed from graft transplanted in the past.The transplanted graft was removed, and the graft was newly transplanted by reoperation.

• Brand Name: EXXCEL SOFT EPTFE VASCULAR GRAFTS
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8914808
• MDR Text Key: 155048978
• Report Number: 2242352-2019-00962
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K131778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: VS004830580
• Device Lot Number: 25059897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 66