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

Catalog Number	1125225-18
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties and foreign body in the patient appear to be related to circumstances of the procedure.Based on the information reviewed, 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 patient underwent a coronary procedure to treat a target lesion in the calcified, 90% stenosed right coronary artery.The 2.25 x 18 mm xience alpine stent delivery system was advanced into the patient anatomy and resistance was noted advancing to the lesion, due to the patient anatomy.The device was pulled back for re-positioning and resistance was noted due to the patient anatomy.It was noted that the stent did not appear to be on the stent delivery system and the device was removed.Upon removal, the stent was not on the stent delivery system.The guide wire was removed from the patient anatomy; however, the stent was not on the guide wire.The stent was not noted to be in the coronary anatomy.Computed tomography of the brain was performed; however, the stent was not seen.No additional intervention has been performed and the patient is under observation.At this time, the patient is in stable condition.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: 5900760
• Report Number: 2024168-2016-05647
• Device Sequence Number: 13551200
• Product Code: NIQ
• UDI-Device Identifier: 08717648199080
• UDI-Public: (01)08717648199080(17)180409(10)5040241
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/24/2016

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 Expiration Date: 04/09/2018
• Device Catalogue Number: 1125225-18
• Device Lot Number: 5040241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2016
• Initial Report FDA Received Date: 08/24/2016
• 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: Other
• Patient Age: 75 YR
• Patient Weight: 76