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

Catalog Number	1125400-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2017
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.Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The resistance with the guide wire was confirmed.The failure to advance could not 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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The bmw guide wire referenced is filed under separate a medwatch report.
Event or Problem Description
It was reported that the patient underwent a coronary stenting procedure to treat a target lesion in the moderately calcified and mildly tortuous mid right coronary artery.The xience alpine stent delivery system was advanced over the balance middleweight (bmw) guide wire.The stent delivery system (sds) was unable to cross to the target lesion and an attempt was made to remove the device; however, during removal, resistance was noted between the sds and the guide wire.The physician tried to remove the sds, but the guide wire separated in the patient anatomy.The separated guide wire segment remained contained in the stent delivery system and the devices were removed as a single unit.All segments of the guide wire were removed from the patient anatomy.No portion of the guide wire remained in the patient anatomy.A second guide wire and xience alpine sds were used to complete the procedure.There was no adverse patient effect and no clinically significant delay.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: 6330866
• Report Number: 2024168-2017-01190
• Device Sequence Number: 19211986
• Product Code: NIQ
• UDI-Device Identifier: 08717648199622
• UDI-Public: (01)08717648199622(17)191130(10)6111941
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/14/2017

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: 11/30/2019
• Device Catalogue Number: 1125400-18
• Device Lot Number: 6111941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: BMW HYDRO