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

Catalog Number	1125250-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/17/2019
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.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.It should be noted that the reported patient effect of death is listed in the xience alpine, everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect 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 that on (b)(6) 2018, a 2.5x15mm xience alpine stent was successfully implanted in the distal left anterior descending (lad) coronary artery lesion.On (b)(6) 2019, the patient expired due to unknown causes.Autopsy was not performed.Per patient's daughter, the patient was not good at managing himself since his wife had passed away and the patient had discontinued plavix use after one month.Per study physician, the death is possibly related to the device.There was no reported device malfunction.No additional information was provided regarding this issue.

• 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: 8659693
• Report Number: 2024168-2019-04274
• Device Sequence Number: 16785882
• Product Code: NIQ
• UDI-Device Identifier: 08717648199165
• UDI-Public: 08717648199165
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2019

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: 01/21/2021
• Device Catalogue Number: 1125250-15
• Device Lot Number: 8011141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 05/31/2019
• 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: Death
• Patient Age: 75 YR
• Patient Weight: 89