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

Catalog Number	1125250-28
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.The reported stent dislodgement was 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 other similar incidents from this lot.Based on the information reviewed, 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 unpackaging and prior to prep, while it had been confirmed that the device was sealed in its packaging, a 2.5x28mm rx xience alpine stent delivery system (sds) was pulled out of its dispenser hoop without difficulty and the protective sheath was removed without difficulty when it was noted that the stent was missing from the balloon.The stent was found to be located inside of the dispenser hoop.The device was not used in the patient.Another xience alpine was unpackaged without issue and used to successfully complete the procedure.This issue did not cause or contribute to a clinically significant delay.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: 6339512
• Report Number: 2024168-2017-01301
• Device Sequence Number: 16275702
• Product Code: NIQ
• UDI-Device Identifier: 08717648199196
• UDI-Public: (01)08717648199196(17)190821(10)6081241
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/17/2017

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: 08/21/2019
• Device Catalogue Number: 1125250-28
• Device Lot Number: 6081241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1