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

Catalog Number	1125300-33
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2016
Type of Reportable Event	Malfunction
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 identified no other similar incidents reported from this lot.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.The investigation was unable to determine a conclusive cause for the difficulties removing the filter; however device damaged by another device and stent damage appear to be related to circumstances of the procedure.
Event or Problem Description
It was reported that the procedure was to treat a saphenous vein graft to the left anterior descending artery.A non-abbott embolic protection system was placed and a 3.0 x 33 mm xience alpine stent was implanted without issue in the proximal portion of the vein graft.The xience alpine delivery catheter was removed without issue.When removing the non-abbott embolic protection filter, there was resistance with the implanted stent and there was significant force applied causing the guiding catheter to move forward and crumple the proximal end of the stent.Attempts were made for a couple of hours to remove the filter but it could not be removed.The patient remained in stable condition throughout the procedure but is being sent to surgery to remove the filter.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: 5880534
• Report Number: 2024168-2016-05457
• Device Sequence Number: 16273920
• Product Code: NIQ
• UDI-Device Identifier: 08717648199387
• UDI-Public: (01)08717648199387(17)190117(10)6010841
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2016

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: 01/17/2019
• Device Catalogue Number: 1125300-33
• Device Lot Number: 6010841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2016
• Initial Report FDA Received Date: 08/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 113