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

Catalog Number	1125325-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The investigation determined a conclusive cause for the reported stent dislodgement cannot be determined.It should be noted that the xience alpine everolimus eluting coronary stent system electronic instructions for use: prior to using the xience alpine stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.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.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 3.25 x 23 mm xience alpine stent delivery system was prepared for use.There was no difficulty noted during removal of the sheath and stylet.The device was advanced into the patient anatomy, to the target lesion, and no difficulty was noted.The physician inflated the balloon to deploy the stent, and then removed the stent delivery system without difficulty.An unspecified dilatation catheter was advanced for post-dilatation of the stent; however, it was noted that there was no stent at the target lesion.It was then noted that the stent was on the back table, where the device was prepared for use.The stent had dislodged from the stent delivery system during preparation of the device, but was not noticed.The stent did not dislodge in the patient anatomy and there was no adverse patient effect.A second xience alpine was then used without issue.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: 6271045
• Report Number: 2024168-2017-00627
• Device Sequence Number: 612811
• Product Code: NIQ
• UDI-Device Identifier: 08717648199455
• UDI-Public: (01)08717648199455(17)190126(10)6011841
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2017

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: 01/26/2019
• Device Catalogue Number: 1125325-23
• Device Lot Number: 6011841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 01/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR