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

Catalog Number 1012817-16

Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Guide wire: sion blue, guide cath: guidezilla ii, sheath: 6f, stent: graftmaster 2.8x16.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The first graftmaster device referenced is being filed under a separate medwatch mfr number.

Event Description

It was reported that that the procedure was to treat a de novo lesion located in the proximal-left circumflex coronary artery.When rotablator was done, a perforation occurred.Two graftmasters were required since the perforation was very large.The first graftmaster covered stent delivery system was used with a guideliner 6f and the stent was successfully deployed.The graftmaster successfully sealed the area in which it was deployed.A second 2.8 x 16 graftmaster was used with the same guideliner, however, resisistance was noted inside the guideliner and the proximal shaft got kinked and separated.The device was removed and replaced with a third graftmaster 2.8 x 16 mm covered stent system but the same issue occurred and the proximal shaft got kinked and separated.The guideliner was replaced with a guidezilla ii and a fourth graftmaster covered stent was successfully deployed and sealed the area in which it was deployed.The procedure was complete.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).A visual inspection was performed on the returned device.The reported kink and shaft detachment were confirmed.The reported difficult to position could not be tested as it was based on operational circumstances.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 appear to be related to the use error as the chipboard box label specifies that the minimum guiding catheter compatibility for a 2.8x16mm graftmaster rx stent is 6f/0.068 inch (1.73mm) inner diameter (id).The reported 6f guideliner brand guide catheter used for the procedure has an id of 0.056 inch (1.42 mm) as specified on the product website.This likely contributed to the reported difficult to position, shaft kink and shaft detachment as resistance was noted during advancement into the guide catheter.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 7382308
• MDR Text Key: 103932342
• Report Number: 2024168-2018-02287
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1012817-16
• Device Lot Number: 6051141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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