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

Catalog Number	1125300-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
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.The sion blue device referenced is being filed under a separate medwatch report.Evaluation summary: the device was returned for analysis.The sds could not be tested to confirm the reported difficulty to advance or difficulty to remove due to the condition in which the sds was returned.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 revealed no other similar incidents reported.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guide wire due to a build up of procedural contaminates on the guide wire resulting in the reported difficulty to advance and remove the sds.Additionally, the interaction with the guide wire and subsequent difficulties caused the additional identified damage to the device.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 lesion located in the circumflex artery.A sion blue guide wire was advanced through the anatomy without issue.After inserting the 3.0 x 12 mm xience alpine stent delivery system (sds) on the proximal end of the guide wire, it became stuck.The decision was made to use the same guide wire so that vessel access would not be lost; therefore, the proximal end of the sion blue guide wire was cut leaving the proximal end inside the delivery system.Another xience alpine sds was used without issue with the same sion blue guide wire.No adverse patient effects or clinically significant delay in the procedure were reported.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: 7131888
• Report Number: 2024168-2017-09948
• Device Sequence Number: 11042596
• Product Code: NIQ
• UDI-Device Identifier: 08717648199332
• UDI-Public: 08717648199332
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/19/2017

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: 08/18/2019
• Device Catalogue Number: 1125300-12
• Device Lot Number: 6081141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR