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

Catalog Number	1125350-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported stent dislodgement was confirmed.The reported difficult to position and to remove were unable to be replicated in a testing environment as it was based on operational circumstances.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.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 and heavily calcified proximal circumflex (cx), left anterior descending artery (lad), and left main arteries.Pre-dilatation was performed with an unspecified balloon catheter.A 3.5 x 12 xience alpine stent delivery system (sds) was being advanced to the lesion through a guideliner that had been advanced past the lesion.As the xience alpine got to the tip of the guideliner, there was resistance, so the guide liner was pulled back, met resistance with the sds, and the stent dislodged inside the guideliner.The sds and guideliner were removed as a single unit, with the stent still in the guideliner.A 3.5 x 8 mm xience alpine sds was advanced to the lad, however, it would not cross due to the anatomy.A 3.0 x 09 non-abbott stent was deployed.A 3.5 x 18 mm xience alpine sds was advanced to the proximal lad, however, it would not cross due to the anatomy.A 3.5 x 18 mm non-abbott stent was deployed.A 4.0 x 12 mm xience alpine and a 4.0 x 8 mm xience alpine stents were implanted in the left main to successfully complete the procedure.There was no clinically significant delay in 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: 7118629
• Report Number: 2024168-2017-09742
• Device Sequence Number: 1411386
• Product Code: NIQ
• UDI-Device Identifier: 08717648199516
• UDI-Public: 08717648199516
• 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): 12/14/2017

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: 07/16/2020
• Device Catalogue Number: 1125350-12
• Device Lot Number: 7071141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR