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

Catalog Number	1125250-23
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Death (1802)
Date of Event	12/15/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction and the device was not returned as the stent remains in the patient.The reported patient effect of death is listed in xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was a high risk percutaneous coronary intervention (pci) to treat a heavily calcified lesion in the left anterior descending (lad) artery, with additional disease noted in the circumflex and right coronary artery, which was totally occluded.An impella device was placed, then pre-dilatation was performed.A 2.5x23mm alpine stent was deployed in the mid to proximal lad and another 2.5x23mm alpine stent was deployed in the left main (lm).Intravascular ultrasound (ivus) was performed and then post-dilatation was performed on both alpine stents with a 2.75 balloon.The stents were confirmed to be well apposed to the vessel wall and the procedure was completed at this time.However, after several minutes, the patient experienced bradycardia, coded and then expired.The physician does not believe there was in-stent thrombosis due to the lack of st elevation.No autopsy was performed.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: 7175244
• Report Number: 2024168-2018-00199
• Device Sequence Number: 13906457
• Product Code: NIQ
• UDI-Device Identifier: 08717648199189
• UDI-Public: 08717648199189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/09/2018

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: 08/03/2020
• Device Catalogue Number: 1125250-23
• Device Lot Number: 7072641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/09/2018
• 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: STENT: 2.5X23 MM XIENCE ALPINE
• Outcome Attributed to Adverse Event: Death