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

Catalog Number	1125225-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient and device codes in f10 were coded by the manufacturer.(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties were likely due to the patient anatomical conditions.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 the procedure was to treat an eccentric de novo lesion in the distal circumflex (cx) artery with heavy tortuosity and heavy calcification that was 90% stenosed.Pre-dilatation was performed using an unknown balloon dilatation catheter.Resistance was felt during advancement of the 2.25 x 15 mm xience alpine rx stent delivery system (sds) to the lesion and would not cross it.During removal of the sds, the proximal edge of the stent implant became stuck with the distal edge of the guiding catheter causing the stent to flare.A new sds was used to complete the procedure.There were no adverse patient effects or clinically significant delay in the procedure 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: 6443560
• Report Number: 2024168-2017-02630
• Device Sequence Number: 18988022
• Product Code: NIQ
• UDI-Device Identifier: 08717648199073
• UDI-Public: (01)08717648199073(17)180204(10)5013041
• 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): 03/29/2017

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: 02/04/2018
• Device Catalogue Number: 1125225-15
• Device Lot Number: 5013041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1