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

Catalog Number	1125350-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2017
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.Concomitant medical products: guide wire: runthrough, guide cath: hyperion.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the anatomy resulting in the reported failure to advance.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 procedure was to treat a heavily tortuous, eccentric and heavily calcified proximal left circumflex artery.After pre-dilatation, an attempt was made to advance a 3.5 x 28 mm xience alpine; however, it could not cross the lesion due to the anatomy.Therefore, the device was removed from the anatomy but as it was being removed, the stent became caught with the tip of a non-abbott guiding catheter, which caused the stent strut to become flared.The device was then removed independently and replaced with another 3.5 x 28 mm xience alpine stent that advanced through an unspecified guideliner 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: 7070696
• Report Number: 2024168-2017-09262
• Device Sequence Number: 13687866
• Product Code: NIQ
• UDI-Device Identifier: 08717648199554
• UDI-Public: 08717648199554
• 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): 11/30/2017

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: 06/11/2020
• Device Catalogue Number: 1125350-28
• Device Lot Number: 7060141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1