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

Catalog Number	1125225-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2016
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 device was returned for analysis.The difficulty removing the device was able to be 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.The investigation determined the reported difficulties to be related to circumstances of the procedure as it is likely the sds interacted with the calcified anatomy, resulting in the failure to advance.Furthermore, the bound up guide wire likely resulted in the resistance removing the sds from the guiding catheter.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 the stenting procedure to treat the target lesion in the moderately calcified mid diagonal artery, pre-dilatation was performed using a trek dilatation catheter.An attempt was made to advance the 2.25 x 28 mm xience alpine stent delivery system; however due to the patient anatomy, the device was unable to cross.The device was removed; however, it became caught at the proximal tip of the guide catheter.The stent did not dislodge and all devices were removed as a single unit.The stenting procedure was completed using a second same device with a new guide catheter and guide wire.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: 6254637
• Report Number: 2024168-2017-00496
• Device Sequence Number: 665295
• Product Code: NIQ
• UDI-Device Identifier: 08717648199103
• UDI-Public: (01)08717648199103(17)190911(10)6090641
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/16/2017

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: 09/11/2019
• Device Catalogue Number: 1125225-28
• Device Lot Number: 6090641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2016
• Initial Report FDA Received Date: 01/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 118