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

Catalog Number	1125250-15
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 reported from this lot.The xience alpine everolimus eluting coronary stent system instructions for use states that the xience alpine stent system is indicated for improving coronary artery luminal diameter in de novo native coronary artery lesions and for treating de novo chronic total coronary occlusions.Use in the vein graft does not appear to have contributed to the reported event.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the unspecified guideliner met resistance with the stent delivery system during retraction; thus, dislodging the stent implant from the balloon.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
The procedure was to treat a moderately tortuous and moderately calcified vein graft.A 2.5 x 15 mm xience alpine stent was used; however, the stent came off the balloon when an unspecified guideliner was being pulled back and hit the stent delivery system.Therefore, another unspecified stent was implanted to embed the xience alpine stent into the vessel wall, and successfully complete the procedure.There was a delay in the procedure; however, the delay was not clinically significant as there was no adverse patient sequela 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: 6805739
• Report Number: 2024168-2017-06808
• Device Sequence Number: 1566553
• Product Code: NIQ
• UDI-Device Identifier: 08717648199165
• UDI-Public: 08717648199165
• 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): 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2020
• Device Catalogue Number: 1125250-15
• Device Lot Number: 7040641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR