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

Catalog Number	1125250-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: guide wire: sion blue, guide catheter: hyperion 6f spb3.5.The device was not returned for analysis.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 reported from this lot.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a 75% stenosed, mildly tortuous, and mildly calcified lesion in the distal circumflex artery.A non-abbott guide wire crossed the lesion and an intravascular ultrasound was performed.A 2.25x23mm xience alpine stent was implanted in the target lesion.A 2.5x8mm xience alpine stent was advanced to the lesion; however, the stent was not confirmed with angiography.It was then noticed that the 2.5x8mm xience alpine stent dislodged inside the y-connector.The dislodged stent was removed from the y-connector and a 2.25x8mm xience alpine was advanced to the lesion using the same y-connector.The procedure was successfully completed.There was no clinically significant delay in the procedure and no adverse patient effects.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: 6478418
• Report Number: 2024168-2017-03005
• Device Sequence Number: 1344462
• Product Code: NIQ
• UDI-Device Identifier: 08717648199141
• UDI-Public: (01)08717648199141(17)190112(10)6010641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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: 01/12/2019
• Device Catalogue Number: 1125250-08
• Device Lot Number: 6010641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2017
• Initial Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1