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

Catalog Number	1125250-38
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817); Thrombosis (2100)
Date of Event	12/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina and thrombosis are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during balloon pre-dilatation of the 90% stenosis in the heavily calcified, distal left circumflex coronary artery, the patient experienced st elevation.A 2.50x38 mm xience alpine stent was successfully deployed, reducing stenosis to 0%.Post-dilatation was not performed.About twenty minutes post procedure, the patient experienced chest pain with st elevation, and was brought back to the cath lab.Activated clotting time (act) was noted to be at 214 seconds with a timi 3 blood flow.Additional heparin was administered.An occlusion/clot was unable to be visualized; however, the physician suspected either a clot or unseen calcium behind the stent may have caused the st elevation.Post stent balloon dilatation was performed and the chest pain and st elevations resolved.An intravenous infusion of integrilin was started.In the opinion of the physician, the stent did not cause or contribute to the patient event.The physician believes the event was due to inadequate anti-coagulation and residual calcium in the vessel.The patient was discharged home on (b)(6) 2017 and was doing great.There was no additional information 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: 7153391
• Report Number: 2024168-2017-10153
• Device Sequence Number: 1979418
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: 08717648199219
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2020
• Device Catalogue Number: 1125250-38
• Device Lot Number: 7072141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/28/2017
• 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