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

Catalog Number	1125275-28
Health Effect - Clinical Codes	Ischemia (1942); Prolapse (2475)
Date of Event	11/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the stent implant was returned for analysis.The reported device damaged by another (explanted stent) was able to be confirmed.Ischemia is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat lesions located in the distal left main to the circumflex (lm to cx).The lesion was treated with a 2.75 x 28 mm xience alpine stent deployed at 16 atmospheres.A shift in plaque was observed to the lad causing a slow blood flow; therefore, an attempt was made to cross a non-abbott guide wire through the implanted stent struts to reach the lad for treatment of the plaque shift; however, it would not cross through the stent strut and the tip of the guide wire became stuck on the stent struts.Retraction of the guide wire resulted in the implanted stent being explanted along with the guide wire.Another 2.75 x 28 mm xience alpine stent was successfully deployed in the lesion and was post-dilated.An attempt was then made to go through the side struts of the deployed stent with a 2.25 x 8 mm xience alpine stent; however, it would not go through the struts.After additional pre-dilatation was performed, another attempt was made with a 2.25 x 12 mm xience alpine which was able to cross through the struts for treatment of the lad.The patient was stable post-procedure.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: 6149913
• Report Number: 2024168-2016-08631
• Device Sequence Number: 889177
• Product Code: NIQ
• UDI-Device Identifier: 08717648199288
• UDI-Public: (01)08717648199288(17)190524(10)6051941
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2016

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: 05/24/2019
• Device Catalogue Number: 1125275-28
• Device Lot Number: 6051941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2016
• Initial Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: RUNTHROUGH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR