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

Catalog Number	1125225-15
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record and complaint history of the reported product could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.The treatment appears to be related to circumstances of the procedure as the dislodged stent was pushed against the artery wall.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Sus voluntary event report mw5065949.
Event or Problem Description
Sus voluntary event report received states: xience alpine everolimus eluting coronary stent system 2.25mm x 15 mm 2.5, ref# (b)(4) manufactured by abbott.The device was being used during a procedure.The stent fell off the device without the stent deploying properly.Undeployed stent could not be removed safely and had to be pushed against the coronary artery.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: 6195558
• Report Number: 2024168-2016-09114
• Device Sequence Number: 1070529
• Product Code: NIQ
• UDI-Device Identifier: 08717648199073
• UDI-Public: (01)08717648199073
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2016

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: 1125225-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention