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

Catalog Number	1550225-18
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 identified no similar incidents from this lot.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use (ifu) states: packaging removal (sheath removal) to be performed prior to system preparation.It is unknown if the ifu deviation related to prepping the sds prior to sheath removal contributed to the reported stent disassembled (poor stent placement).The investigation was unable to determine a conclusive cause for the reported device disassembled during manufacturing; however, the device was prepped prior to sheath removal (against instructions for use) which may have contributed to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other xience sierra device referenced is being filed under a separate medwatch report.
Event or Problem Description
It was reported both of the 2.25x18mm rx xience sierra stent delivery systems (sds) were prepped prior to removal of the protective sheath.After removal of the sheath, the stent was noted to be mislocated on both of the sds.The procedure was completed with a non-abbott sds.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 7692477
• Report Number: 2024168-2018-05496
• Device Sequence Number: 2770928
• Product Code: NIQ
• UDI-Device Identifier: 08717648227028
• UDI-Public: 08717648227028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2021
• Device Catalogue Number: 1550225-18
• Device Lot Number: 8021341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2018
• Initial Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1