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

Catalog Number	1125250-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The xience alpine everolimus eluting coronary stent system instructions for use states: although the safety and effectiveness of treating more than one lesion per coronary artery with xience alpine stents have not been established, if this is performed, place the stent in the distal lesion before the proximal lesion in order to minimize dislodgement risk incurred by traversing through deployed stents.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 difficulties appear to be related to the use error as it is likely the device interacted with the previously implanted stent during advancement resulting in the reported failure to advance and material deformation (flared stent).Further interaction with the previously implanted stent during retraction of the stent delivery system (sds) likely contributed to the reported difficult to remove.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 during a saphenous vein graft procedure in the circumflex artery, which did not have any tortuosity or calcification, an attempt was made to cross a 2.5 x 12 mm xience alpine stent through an unspecified implanted stent in the lesion.However, the xience alpine stent failed to cross the lesion because it got stuck with the implanted stent, and the struts of the xience alpine stent became flared as well.The alpine stent catheter system was therefore pulled out of the anatomy, and dilatation was done in the lesion.Another 2.5 x 12 mm xience alpine stent was then implanted to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.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: 6959732
• Report Number: 2024168-2017-08311
• Device Sequence Number: 913081
• Product Code: NIQ
• UDI-Device Identifier: 08717648199158
• UDI-Public: 08717648199158
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/18/2017

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: 06/14/2019
• Device Catalogue Number: 1125250-12
• Device Lot Number: 6060241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1