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

Catalog Number 1007844-08

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a totally occluded mid left anterior descending artery.A 4.0 x 8 mm vision stent delivery system was advanced to the lesion; however, the stent was damaged and was not deployed.Another stent was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual inspection was performed on the returned device.The reported material deformation was confirmed.The reported failure to deploy could not be tested due to the device condition.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.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined that the reported difficulties appear to be related to circumstances of the procedure.

• Brand Name: MULTI-LINK RX VISION 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: 5740306
• MDR Text Key: 47935379
• Report Number: 2024168-2016-04054
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P020047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2016

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: 01/31/2016
• Device Catalogue Number: 1007844-08
• Device Lot Number: 3022041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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