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

Catalog Number 1007850-28

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2017

Event Type  malfunction  

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.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The 3.5 x 28 mm xience alpine referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a right coronary artery.A 4.0 x 28 mm vision stent delivery system was advanced to the lesion and inflated; however, the stent would not come off the balloon.The delivery catheter was removed with the stent still on the balloon.Then a 3.5 x 28 mm xience alpine stent delivery system was being advanced through the guiding catheter when there was slight resistance felt.The stent was successfully deployed in the lesion; however, the balloon would not deflate and was removed from the anatomy still inflated.There was no resistance noted when removing the delivery catheter.A non-abbott stent was implanted to successfully 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).A visual and functional inspection were performed on the returned device.The reported failure to deploy could not be confirmed.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 was unable to determine a conclusive cause for the reported failure to deploy; however, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 6891999
• MDR Text Key: 87872172
• Report Number: 2024168-2017-07750
• 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,Followup
• Report Date: 10/04/2017

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: 11/30/2019
• Device Catalogue Number: 1007850-28
• Device Lot Number: 6120541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/25/2017
• Supplement Dates Manufacturer Received: 10/03/2017
• Supplement Dates FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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