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	10/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The additional 3.0x33mm xience alpine referenced is being filed under a separate medwatch mfr number.The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the failure to cross, entrapment of the device, and device caused damaged to another device; however the subsequent treatments appear to be related to circumstances of the procedure.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.It should be noted the xience alpine everolimus eluting coronary stent system electronic instructions for use states: although the safety and effectiveness of treating more than one lesion per coronary artery with xience alpine stents have not been established, if this is performed, place the stent in the distal lesion before the proximal lesion in order to minimize dislodgement risk incurred by traversing through deployed stents.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 procedure was to treat a right coronary artery (rca).A 3.0 x 33 mm xience alpine stent was implanted without issue.A second 3.0 x 33 mm xience alpine stent was advanced through the implanted stent; however, it could not cross to the desired location for deployment.A decision was made to remove the undeployed xience alpine so a guideliner could be used for additional support.When attempting to remove the stent delivery system, it caught halfway inside the guiding catheter and the deployed stent.The device could not be removed so the patient was taken to surgery where they did a bypass of the rca and also of the left anterior descending (lad) artery.During the surgery, the implanted xience alpine was explanted.The patient is doing well and has been moved from the intensive care unit.There was a clinically significant delay in the procedure.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: 6017903
• Report Number: 2024168-2016-06840
• Device Sequence Number: 40493
• Product Code: NIQ
• UDI-Device Identifier: 08717648199387
• UDI-Public: (01)08717648199387(17)190117(10)6010841
• 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): 10/11/2016

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: 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: 10/03/2016
• Initial Report FDA Received Date: 10/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: 3.0 X 33 XIENCE ALPINE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 56 YR
• Patient Weight: 75