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

Catalog Number	1125350-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
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.Incorrect prep.The device was not returned for analysis.The lot history record review and similar incident query for this product was not performed because the lot number was not reported.It should be noted that the xience alpine everolimus eluting coronary stent system instruction for use, states: while introducing the delivery system into the vessel, do not induce negative pressure on the delivery system.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device, after being prepped in the anatomy (against instructions for use) and inflated slightly prior to retraction, interacted with the patients anatomy during removal, and in turn caused the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was to treat a lesion with mild tortuosity and heavy calcification in the left anterior descending coronary artery.A 3.5 x 12 mm xience alpine stent delivery system (sds) was advanced without resistance to the target lesion.The xience alpine was prepped inside the anatomy and just when starting to inflate to 1 atmosphere, the physician realized that the stent was to long for the lesion and stopped the procedure.The physician had misjudged the lesion length; there was no labeling issue.The xience alpine was withdrawn from the patients anatomy without resistance.Outside the anatomy, it was noted that the stent was not on the balloon.The stent had dislodged at the lesion; therefore, a snare device was used to retrieve the dislodged stent without patient consequences.A 3.5 x 8 mm xience alpine stent was used to complete the procedure successfully.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: 7236310
• Report Number: 2024168-2018-00780
• Device Sequence Number: 1017295
• Product Code: NIQ
• UDI-Device Identifier: 08717648199516
• UDI-Public: 08717648199516
• 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): 02/01/2018

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 Catalogue Number: 1125350-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/02/2018
• 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