MAUDE Adverse Event Report: MAQUET CV FUSION 8MM-40CM SUPP PERIPHERAL GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number VS015030480

Device Problems Unraveled Material (1664); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There are no ncmr¿s which could be considered related to the reported event recorded in the lot history.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 that during an aortic arch replacement procedure, fusion 8mm-40cm supp peripheral graft was used for bypass the left common carotid artery and the left clavicular artery.When peeling off the support coil on the graft, part of the graft surface got torn off with the support coil.The hospital proceeded with removing another 2 cm of the support coil, then he was able to remove just the support coil without issue.The graft was implanted and the surgery was finished with no adverse event.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number trackwise # (b)(4).Autonumber # (b)(4).The device history record (dhr) was reviewed for the reported lot.There were no non-conformities observed.The lot conformed to all specification's signs of clinical use and evidence of blood was observed.A piece of the fusion about 3 cm in length was returned for investigation.It was observed that the textile was torn off at the edge of the graft by the area where the support ring bead was being peeled.No other defects were observed.Based on the returned device and the evaluation results, the reported failure was confirmed.

Event Description

The hospital reported that during an aortic arch replacement procedure, fusion 8mm-40cm supp peripheral graft was used for bypass the left common carotid artery and the left clavicular artery.When peeling off the support coil on the graft, part of the graft surface got torn off with the support coil.The hospital proceeded with removing another 2 cm of the support coil, then he was able to remove just the support coil without issue.The graft was implanted and the surgery was finished with no adverse event.The hospital did not report any patient effects.

• Brand Name: FUSION 8MM-40CM SUPP PERIPHERAL GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8095892
• MDR Text Key: 128204434
• Report Number: 2242352-2018-01202
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: VS015030480
• Device Lot Number: 25137051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1