MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1125275-23

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Stretched (1601); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported unstable stent and the reported stretched was able to be confirmed.The reported difficult to position and the reported difficult to remove were unable to be replicated in a testing environment 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 other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a lesion located in the mid-left anterior descending coronary artery that was moderately tortuous, non-calcified and 75% stenosed.The 2.75 x 23 mm xience alpine stent delivery system (sds) was advanced in the guiding catheter (gc) without resistance between the inner diameter of the guiding catheter and the sds until the sds reached the very distal part of the guiding catheter.When the sds reached the distal end of the gc, the stent area got stuck inside the tip of the gc.The stent implant had slightly exited from the tip of the gc when this occurred.Then, attempts were made to advance and remove the sds by pushing the sds and pulling it, but in vain.The sds remained stuck in the guiding catheter.When the final attempt to remove/pull the sds was made, the balloon of the xience alpine was stretched, causing the stent implant to shift on the balloon of the sds but did not dislodge in the coronary artery.The entire system was removed from the anatomy as a single unit.Once outside the anatomy, attempts to separate the devices were made.However, as the non-abbott guide wire remained stuck inside the xience alpine sds, the shaft of the xience alpine sds and the guide wire were cut so that the devices would be removed from one another.A new xience alpine was used to complete the procedure.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).The device was returned for analysis.The reported difficult to position was able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment 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 other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filed medwatch report, follow-up with the physician confirmed that the non-abbott guide wire was inserted into the xience alpine stent delivery system (sds) and the sds was advanced over the guide wire but resistance met between the xience alpine sds and the guide wire as the sds was advanced approximately 10-15cm over the guide wire.The xience alpine sds was pushed and pulled but the sds did not advance nor could it be pulled proximally.The event occurred outside the anatomy (the xience alpine sds did not enter the rhv/guiding catheter).The stent implant of the xience alpine sds was dislodged outside the anatomy.The timing of the stent dislodgement was not specified.The sds and the guide wire were cut to separate the devices outside the anatomy but in vain.No further information is available.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING 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: 7065580
• MDR Text Key: 93449429
• Report Number: 2024168-2017-09212
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199271
• UDI-Public: 08717648199271
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• 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: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2020
• Device Catalogue Number: 1125275-23
• Device Lot Number: 7022041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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