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

Catalog Number	1074225-15
Health Effect - Clinical Code	Death (1802)
Date of Event	01/21/2017
Type of Reportable Event	Death
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.Based on the case information and related record review, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, death is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.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 on (b)(6) 2014 was to treat the left circumflex (lcx) and posterior lateral (pl) arteries.On (b)(6) 2013 the patient had a myocardial infarction.On (b)(6) 2014, a 2.5 x 38 mm xience xpedition stent was implanted in the distal lcx and a 2.25 x 15 mm xience xpedition stent was implanted in the pl.Starting in (b)(6) 2015 through (b)(6) 2016 the patient was admitted to the hospital numerous times for aspiration pneumonitis which was treated with medication.There was no relationship to the stents and the hospital admissions.The patient was suspected to have systemic lupus erythematosus (sle).Additionally the patient was anemic and had liver cancer.On (b)(6) 2017 the patient died.No additional information was provided.

• 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: 6366808
• Report Number: 2024168-2017-01652
• Device Sequence Number: 1081535
• Product Code: NIQ
• UDI-Device Identifier: 08717648162039
• UDI-Public: (01)08717648162039(17)160412(10)4040841
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2017

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: 04/12/2016
• Device Catalogue Number: 1074225-15
• Device Lot Number: 4040841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2017
• Initial Report FDA Received Date: 02/28/2017
• 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: 2.5 X 38 MM XIENCE XPEDITION
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Weight: 58