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

Catalog Number	1074350-12
Health Effect - Clinical Code	Death (1802)
Date of Event	03/13/2017
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.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 xpedition everolimus eluting coronary stent systems instructions for use (ifu) 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
Excel study report.It was reported that on (b)(6) 2013, a 4.0x18mm and 3.5x12mm xience xpedition stents were successfully implanted in the left main coronary artery (lm), proximal left anterior descending (lad), and proximal circumflex (cx) coronary artery lesions.In the year 2015, a percutaneous intervention was performed in the right coronary artery (rca).On (b)(6) 2017, the patient passed away due to an undetermined reason.Per physician, the device relationship to the death was unknown.There was no autopsy performed.No additional information was provided regarding this issue.

• Brand Name: XIENCE XPEDITION 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: 7602850
• Report Number: 2024168-2018-04480
• Device Sequence Number: 209925
• Product Code: NIQ
• UDI-Device Identifier: 08717648162527
• UDI-Public: 08717648162527
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 01/29/2014
• Device Catalogue Number: 1074350-12
• Device Lot Number: 3012141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/14/2018
• 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: XIENCE XPEDITION 4.0X18MMASPIRIN, CLOPIDOGREL
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR
• Patient Weight: 81