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

Catalog Number	1125400-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2017
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.(b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported shaft kink was able to be confirmed.The reported difficulty to insert was unable to be replicated in a testing environment due to the condition of the returned device.It should be noted that the xience alpine everolimus eluting coronary stent system instructions for use states: the xience alpine stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length 32 mm) with reference vessel diameters of 2.25 mm to 4.25 mm.In addition, the xience alpine stent system is indicated for treating de novo chronic total coronary occlusions.Manipulation of the device resulted in the reported/noted hypotube kink(s) and ultimately resulted in the noted shaft detachment.There is no indication of a product quality issue with respect to design, manufacture or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the tibial-fibular trunk that was non-tortuous.The xience alpine 4 x 38 mm stent delivery system could not be loaded in the 6fr sheath and when removed, the stent shaft was kinked.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.Device analysis on 6/8/2017 revealed the hypotube was separated.

• 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: 6662098
• Report Number: 2024168-2017-05283
• Device Sequence Number: 57858
• Product Code: NIQ
• UDI-Device Identifier: 08717648199660
• UDI-Public: (01)08717648199660(17)200319(10)7030941
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/22/2017

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: 03/19/2020
• Device Catalogue Number: 1125400-38
• Device Lot Number: 7030941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 68