MAUDE Adverse Event Report: AV-TEMECULA-CT GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

Catalog Number 1012581-16

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A visual, functional and dimensional inspection was performed on the returned device.The reported shaft detachment was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.The reported difficult to position could not be tested due to the condition of the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure, as it is likely the stent interacted with the heavily calcified anatomy during advancement, thus causing the reported failure to advance.Further interaction with the guide catheter/guideliner, as resistance was noted, likely contributed to the reported difficult to position.Further manipulation while retracting the device contributed to the noted stretched and torn inner member, ultimately causing the reported shaft separation.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The 3.5x26mm graftmaster covered stent referenced is being filed under a separate medwatch report.

Event Description

It was reported that the patient presented with a perforation in the proximal circumflex artery.A 3.5x16mm graftmaster covered stent met resistance when advancing with the anatomy and guide catheter/guideliner.The shaft separated and was removed by hand as some of the catheter was still outside the patient.A 3.5x26mm graftmaster covered stent met resistance when advancing with the guide catheter/guideliner and the distal shaft separated.The shaft separated inside the guide and was pulled out without issues.A 2.80x19mm graftmaster covered stent was used to successfully seal the perforation.No additional information was provided.There was no reported device or patient issue associated with this device.The device was used successfully to seal the perforation; therefore, this will be captured as a non-complaint/product experience.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7526022
• MDR Text Key: 108652449
• Report Number: 2024168-2018-03705
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648176395
• UDI-Public: 08717648176395
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 1012581-16
• Device Lot Number: 7052541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• 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: 76 YR
• Patient Weight: 60