MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC FUSION 8MM-60CM SUPP PERIPHERAL GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number FUSION 8MM-60CM SUPP PERIPHERAL GRAFT

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2021

Event Type  Injury  

Manufacturer Narrative

Trackwise id # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported using fusion 8mm-60cm supp peripheral graft, hemorrhage from approx 180 mm from the proximal side of fusion graft.Fusion graft was torn and connected only by the support ring.Fusion graft implanted in a brachiocephalic artery to right common iliac artery bypass in (b)(6) 2018.Explanted fusion graft and implanted gore-tex peripheral viabahn stent graft.Finished without any problems.

Event Description

The hospital reported using fusion 8mm-60cm supp peripheral graft, hemorrhage from approx 180 mm from the proximal side of fusion graft.Fusion graft was torn and connected only by the support ring.Fusion graft implanted in a brachiocephalic artery to right common iliac artery bypass on (b)(6) 2018.Explanted fusion graft and implanted gore-tex peripheral viabahn stent graft.Finished without any problems.Patient stable.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: h3- corrected to "device discarded".Analysis of production: (3331/213/67) the device history records review concluded that there were ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period (b)(6) 2019 through (b)(6) 2021 was reviewed.There were no triggers identified for the review period device discarded: (4115/213/3221/67) despite request and/ or customer indicated that the device was discarded; however, the actual device involved in the adverse event had been already discarded and thus irretrievably lost for testing.H3 other text : device discarded.

• Brand Name: FUSION 8MM-60CM SUPP PERIPHERAL GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 11356022
• MDR Text Key: 232846015
• Report Number: 2242352-2021-00147
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384409005737
• UDI-Public: 00384409005737
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: FUSION 8MM-60CM SUPP PERIPHERAL GRAFT
• Device Catalogue Number: VS015030680
• Device Lot Number: 25137568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/20/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2018
• Is the Device Single Use?: No
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 72 KG