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

Catalog Number 1012581-26

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported shaft detachment was confirmed.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 identified no similar incidents from this lot.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 delivery system, which was not properly supported or coaxially aligned, interacted with the guide catheter/guideliner, as resistance was noted, which contributed to the reported difficult to position.Further manipulation while advancing/retracting the device contributed to 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 3.5x16mm 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.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: the reported kinked shaft was confirmed.Further manipulation while advancing/retracting the device contributed to the reported kinked shaft.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

Subsequent to the previously filed report, additional information was received stating: the shaft of the 3.5x26mm graftmaster covered stent kinked before the shaft separated.No additional information was provided.

• 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: 7526094
• MDR Text Key: 108653994
• Report Number: 2024168-2018-03707
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

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: 10/31/2018
• Device Catalogue Number: 1012581-26
• Device Lot Number: 6111641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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