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

Catalog Number	1074350-38
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.The reported stent dislodgement was confirmed.Reportedly, the stent delivery system was being prepped with a very brief negative pressure being pulled but not sustained before the sheath/stylet were removed.Per the xience xpedition everolimus eluting coronary stent system instructions for use the mandrel and the protective sheath should be removed before flushing the guide wire lumen and removing air from the system.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 other incidents from this lot.As there were crimp marks on the balloon between the markers where the stent implant was initially crimped on, it is likely that inadvertent mishandling while removing the protective sheath resulted in the noted stent damage (stretched) and ultimately resulted in 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 that the stent of a 3.5x38mm xience xpedition stent delivery system (sds) dislodged during removal of the protective sheath.Additionally, the sds was being prepped with a very brief negative pressure being pulled but not sustained before the sheath/stylet were removed.The device was not used and the procedure was successfully completed with another device.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 6889039
• Report Number: 2024168-2017-07722
• Device Sequence Number: 16174280
• Product Code: NIQ
• UDI-Device Identifier: 08717648162589
• UDI-Public: 08717648162589
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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: 06/22/2020
• Device Catalogue Number: 1074350-38
• Device Lot Number: 7061641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1