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

Catalog Number	1009543-15
Health Effect - Clinical Codes	Angina (1710); Death (1802); Dyspnea (1816); Stenosis (2263)
Date of Event	10/06/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: stent: promus element plus 4.0x24, three xience primes (two 4.0x38s), (one 3.5x38); other: aspirin, clopidogrel.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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of angina, stenosis, and death are listed in the xience v everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The 3.5x38 rx xience prime referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2013 four xience stents were implanted in the proximal, mid, and distal right coronary artery (rca).On (b)(6) 2016 the patient had stable angina with dyspnea/shortness of breath.Diagnostic coronary angiography was performed and the condition resolved.Percutaneous coronary intervention was performed for restenosis in the proximal and distal rca study lesions.The patient expired on (b)(6) 2017 of unknown cause.There was no additional information provided.

• Brand Name: XIENCE V 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: 7180932
• Report Number: 2024168-2018-00274
• Device Sequence Number: 13730624
• Product Code: NIQ
• UDI-Device Identifier: 08717648064418
• UDI-Public: 08717648064418
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P070015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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: 03/25/2014
• Device Catalogue Number: 1009543-15
• Device Lot Number: 2030741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/10/2018
• 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: 70 YR
• Patient Weight: 128