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

Catalog Number	1145350-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
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).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 identified no other similar incidents from this lot.The xience alpine everolimus eluting coronary stent system instructions for use (ifu) states that the device is indicated for use in the coronary artery.Also, per the ifu, before use, carefully remove the system from the package and inspect for bends, kinks and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.The violations of the ifu do not appear to have contributed to the reported stent dislodgement and the investigation determined a conclusive cause for the reported difficulties could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device labeling.
Event or Problem Description
It was reported that during device preparation, when removing the stylet, the stent dislodged from the balloon; however, the device was not inspected prior to use and the stent delivery system was advanced through the non-tortuous vessel to the moderately calcified, anterior tibial artery lesion.It was then noted that the stent was not on the balloon and was found on the back table attached to the stylet.There was no reported adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE ALPINE OTW 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: 6790048
• Report Number: 2024168-2017-06635
• Device Sequence Number: 1080757
• Product Code: NIQ
• UDI-Device Identifier: 08717648200298
• UDI-Public: 08717648200298
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/11/2017

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: 01/08/2020
• Device Catalogue Number: 1145350-38
• Device Lot Number: 6122141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 73