MAUDE Adverse Event Report: AV-TEMECULA-CT MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

Catalog Number 1007821-12

Device Problems Positioning Failure (1158); Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The investigation determined the reported failure to deploy, physical resistance and shaft kink appears to be related to circumstances of the procedure.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that resistance was met advancing the 2.0x12 mini vision stent delivery system (sds) to the heavily calcified target lesion in the mid left anterior descending coronary artery.The sds crossed the lesion but the stent was unable to be deployed.The sds with the undeployed stent was removed from the anatomy when it was noted that there was a kink in the shaft.The kinked shaft was thought to be the cause of the failure to deploy the stent.A non-abbott stent was used to complete the procedure without further incident.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
• Type of Device: CORONARY STENT SYSTEM
• 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: 5199546
• MDR Text Key: 30569034
• Report Number: 2024168-2015-06557
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020047
• 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: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 1007821-12
• Device Lot Number: 3032641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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