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

Catalog Number	1125350-15
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) medical devices: guide wire: pt graphix.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined that the reported failure to advance, stent dislodgement, difficult to remove and foreign body in patient appear to be related to circumstances of the procedure.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 performed to treat a lesion in the heavily tortuous saphenous vein graft.The 3.5 x 15 mm xience alpine stent delivery system (sds) was advanced into the patient anatomy and an attempt was made to cross through a previously implanted unspecified stent to get to the target lesion that was distal to the implanted stent.The sds was unable to cross and the guide catheter was advanced further into the vessel.An attempt was made to remove the sds; however, resistance was noted with the anatomy and all devices were removed as a single unit.Upon removal, it was noted that the stent was no longer on the sds.The stent could not be located on the devices or in the patient anatomy.It is possible that the stent remains in the anatomy, as it could not be located within the devices.The procedure continued with implantation of a 3.5 x 16 mm non-abbott 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: 7741076
• Report Number: 2024168-2018-05955
• Device Sequence Number: 11025448
• Product Code: NIQ
• UDI-Device Identifier: 08717648199523
• UDI-Public: 08717648199523
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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 Expiration Date: 02/18/2021
• Device Catalogue Number: 1125350-15
• Device Lot Number: 8013161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/01/2018
• 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: Other
• Patient Age: 77 YR