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

Catalog Number	1009542-12
Health Effect - Clinical Codes	Angina (1710); Bradycardia (1751); Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Date of Event	02/10/2017
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.The reported patient effects of angina, death, and ventricular fibrillation are listed in the xience v everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2012 during an elective procedure, the patient had a 2.75 x 24 mm non-abbott stent was implanted in the posterolateral of the left circumflex and a 3.50 x 12 mm xience v stent implanted in the proximal left circumflex.On (b)(6) 2012, (b)(6) 2014 and (b)(6) 2015.The patient had follow-up visits and no issues were noted.On (b)(6) 2017 the patient experienced tightness in the chest at home and was transported to the hospital by ambulance.After arriving at the hospital, the patient exhibited increasing symptoms of bradycardia eventually resulting in cardiopulmonary arrest.Cardiopulmonary resuscitation (cpr) was attempted several times.However, during the cpr ventricular fibrillation (vf) occurred and defibrillation attempts were made but they were in vain.The patient died on (b)(6) 2017.In the opinion of the physician, based on the condition of the patient and the circumstances, the death was cardiac death.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: 6431723
• Report Number: 2024168-2017-02482
• Device Sequence Number: 780022
• Product Code: NIQ
• UDI-Device Identifier: 08717648064234
• UDI-Public: (01)08717648064234(17)130810(10)1072841
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2017

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: 08/10/2013
• Device Catalogue Number: 1009542-12
• Device Lot Number: 1072841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/24/2017
• 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: 2.75 X 24 MM NOBORI
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR