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

Catalog Number	1009541-23
Health Effect - Clinical Codes	Angina (1710); Death (1802)
Date of Event	06/30/2015
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.The reported patient effects of angina and death are listed in the xience v everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.
Event or Problem Description
It was reported that the procedure on (b)(6) 2010 was to treat three lesions.A 3.5 x 28 mm xience v stent was implanted in the proximal right coronary artery.A 3.0 x 23 mm xience v stent was implanted in the mid left anterior descending artery and a non-abbott stent was implanted in the left main artery.On (b)(6) 2010 follow-up angiography was performed and no symptoms were noted.The patient was compliant with dual antiplatelet therapy (dapt).On (b)(6) 2014 the patient presented with angina.It is unknown if treatment was performed.On (b)(6) 2015 follow-up angiography was performed and no symptoms were noted.Dapt had been stopped on (b)(6) 2010.On (b)(6) 2015 the patient expired.The cause of death is unknown.No additional information was 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: 5869800
• Report Number: 2024168-2016-05340
• Device Sequence Number: 270143
• Product Code: NIQ
• UDI-Device Identifier: 08717648064135
• UDI-Public: (01)08717648064135
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2016

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 Catalogue Number: 1009541-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2016
• Initial Report FDA Received Date: 08/11/2016
• 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: 3.5 X 28 MM XIENCE V
• Outcome Attributed to Adverse Event: Death
• Patient Age: 72 YR