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

Catalog Number	1125225-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2017
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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sds was advanced resistance was met with the implanted non-abbott stent resulting in the reported failure to advance.When removing the sds, the alpine stent was caught on the implanted stent resulting in the reported difficulty to remove.Manipulation of the device resulted in the reported stent dislodgment.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 2.25x23mm xience alpine stent delivery system (sds) failed to cross through a non-abbott implanted stent.When removing the sds, the alpine stent was caught on the implanted stent and the alpine stent dislodged in the anatomy.A balloon dilatation catheter and snare device were used to remove the dislodged stent from the patient anatomy.When snaring the dislodged stent, the non-abbott stent was explanted.A larger xience alpine stent was implanted.The patient is stable.There was clinically significant delay during 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: 6969582
• Report Number: 2024168-2017-08394
• Device Sequence Number: 1145821
• Product Code: NIQ
• UDI-Device Identifier: 08717648199097
• UDI-Public: 08717648199097
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/23/2017

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: 11/15/2019
• Device Catalogue Number: 1125225-23
• Device Lot Number: 6110741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 10/23/2017
• 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