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

Catalog Number	1125400-33
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.The reported dislodged stent was able to be confirmed.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 similar incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The xience alpine instructions for use (ifu) states to remove the product mandrel and protective stent sheath prior to removing air from the system.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as the violation of the ifu of not removing the protective sheath and mandrel prior to preparing the device in conjunction with inadvertent mishandling during sheath removal resulted in the reported dislodged stent.
Event or Problem Description
It was reported that during preparation of the 4.00 x 33 mm xience alpine stent delivery system (sds) the stent implant became dislodged from the balloon and was found inside the protective sheath.There was no resistance felt during removal of the sds from the hoop/coil.The sds was prepped (air aspiration) prior to the removal of the product mandrel and stent sheath and there was no resistance felt during their removal.The xience alpine sds was not used in the procedure.There was no patient involvement.There was no reported clinically significant delay in the procedure.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: 6153487
• Report Number: 2024168-2016-08674
• Device Sequence Number: 894161
• Product Code: NIQ
• UDI-Device Identifier: 08717648199653
• UDI-Public: (01)08717648199653(17)180317(10)5031141
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2016

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: 03/17/2018
• Device Catalogue Number: 1125400-33
• Device Lot Number: 5031141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2016
• Initial Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1