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

Catalog Number	1125250-12
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned.A review of the lot history record and complaint history could not be conducted since the lot number was not provided.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the stent delivery system (sds) was advanced resistance was met with the heavily calcified, moderately tortuous anatomy resulting in the reported failure to advance and the reported stent dislodgement from the balloon.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during a heavily calcified, moderately tortuous left main coronary artery to ostial circumflex artery, the 2.5x12 mm xience alpine stent delivery system met resistance and the stent dislodged in the left main.Attempts to remove the dislodged stent with a balloon were unsuccessful.Balloon dilatation was performed and a non-abbott stent was used to embed the dislodged stent in the left main.Another non-abbott stent was implanted to complete the procedure.There was no reported clinically significant delay in procedure.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 6984505
• Report Number: 2024168-2017-08514
• Device Sequence Number: 488952
• Product Code: NIQ
• UDI-Device Identifier: 08717648199158
• UDI-Public: 08717648199158
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1125250-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: GUIDELINER
• Outcome Attributed to Adverse Event: Required Intervention