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

Catalog Number	1145225-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.The reported difficult to remove was able to be confirmed.The reported difficult to position 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.The bmw guide wire is being filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous right coronary artery.A balance middleweight (bmw) guide wire was advanced to the lesion.A 2.25 x 23 otw xience alpine was being advanced over the guide wire without resistance; however, the guide wire backed out slightly so the physician tried to advance the guide wire when there was resistance with the catheter.An attempt was made to remove the catheter, but at the guiding catheter tip, there was resistance again with the guide wire so the devices were removed from the anatomy as a single unit.Outside the anatomy, it was noted that the guide wire tip had separated and the coils had stretched and some of them were entwined with the stent struts.An attempt was made to remove the guide wire so it is unknown if the coils are still entwined with the stent.There was no part of the guide wire left in the anatomy.The procedure was completed with a new guide wire and stent delivery system.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

• Brand Name: XIENCE ALPINE OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7060243
• Report Number: 2024168-2017-09165
• Device Sequence Number: 821100
• Product Code: NIQ
• UDI-Device Identifier: 08717648199813
• UDI-Public: 8717648199813
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2019
• Device Catalogue Number: 1145225-23
• Device Lot Number: 6072141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1