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
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2242352-2021-00147
• Device Sequence Number: 16980198
• Product Code: DSY
• UDI-Device Identifier: 00384409005737
• UDI-Public: 00384409005737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 02/20/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 72 KG