MAUDE Adverse Event Report: ABBOTT XIENCE ALPINE

Model Number 1125225-12

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Defective Component (2292); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/11/2017

Event Type  Injury  

Event Description

While doing a pci of the left main coronary art.Stent number 1) 2.25 x 12 xience alpine ref # 1125225-12 lot # 7030641 was attempted to be placed in lca through a stent which had been placed in the cx."jailing" the lca, unable to advance the stent upon removing the stent from the body was found to be defected.This stent was retained.Stent number 2) 2.5 x 15 xience alpine ref 1125250-15 lot 7012341 while attempting to place this stent into the lca (as above) the stent became dislodged from balloon.Negative pressure had not been applied to the balloon before the stent came off.Dr.(b)(6) left the wire down the art and attempted to "catch" the sent in the end of the catheter.Removed the catheter after catching the stent at the end of the catheter, stent came out of catheter and traveled down the right leg when the catheter reached the sheath.Stent was located by fluro and retrieved by use of snare, removed stent, snare and balloon all retained.

• Brand Name: XIENCE ALPINE
• Type of Device: XIENCE ALPINE
• Manufacturer (Section D): ABBOTT; santa clara CA 95054
• MDR Report Key: 6639587
• MDR Text Key: 77619390
• Report Number: MW5070390
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2017
• Device Model Number: 1125225-12
• Device Lot Number: 7030641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR