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 Consequences Or Impact To Patient (2199)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The investigation determined an interaction with the heavily tortuous lesion contributed to the failure to cross and the stent becoming disrupted on the balloon such that it subsequently dislodged.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.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 the procedure was to treat a de novo lesion located in the left anterior descending artery (lad) with heavy tortuosity and mild calcification.The 2.50 x 28 mm xience alpine stent delivery system (sds) was advanced to the lesion during a direct stenting procedure, but it was unable to cross the bend in the left main.When the sds was removed from the anatomy, the stent implant dislodged from the sds and remained in the left main artery.There was no resistance while removing the sds.A snare device was used to recover the stent; however, the stent was unable to be pulled through the guiding catheter.Radial arterial cut down was performed to remove the dislodged stent.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: 6221774
• Report Number: 2024168-2017-00048
• Device Sequence Number: 16245274
• Product Code: NIQ
• UDI-Device Identifier: 08717648199196
• UDI-Public: (01)08717648199196(17)190911(10)6090641
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/04/2017

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: 09/11/2019
• Device Catalogue Number: 1125250-28
• Device Lot Number: 6090641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 01/04/2017
• 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
• Patient Age: 63 YR
• Patient Weight: 73