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

Catalog Number	1125275-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Myocardial Infarction (1969); Ventricular Tachycardia (2132)
Date of Event	06/29/2018
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.There was no reported device malfunction and 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 death, cardiac arrest, myocardial infarction and ventricular tachycardia are listed in the xience alpine everolimus eluting coronary stent system, instructions for use as known patient effects.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 manufacture, design or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient was admitted with chest pain and underwent a coronary stenting procedure, with placement of a 2.75 x 33 mm xience alpine stent in the mid left anterior descending artery and a 3.0 x 12 mm xience alpine stent in the proximal circumflex artery.The patient returned to the emergency department two days later, with severe chest pain.Coronary angiogram noted the stents were patent, but computed tomography showed a penetrating ulcer of the descending thoracic and proximal abdominal aorta.The patient underwent a thoracic endovascular aortic/aneurysm repair (tevar) procedure to repair the aortic ulcer.The patient was found to have bilateral lower extremity paralysis following the endovascular repair, which was due to probable spinal ischemia at the t10 (thoracic) level.The patient remained hospitalized until (b)(6) 2018 and transferred to a rehabilitation facility for continued care.At the rehabilitation facility, the patient developed sepsis, with e.Coli cultured in the urine and blood.The patient was treated with intravenous (iv) antibiotics.The patient became septic, hypotensive and short of breath and was transferred back to the hospital on (b)(6) 2018.The abdominal aneurysm had increased in size.The patient was evaluated and a possible pocket of infection was noted around the tevar graft; however, exploratory surgery was postponed until the patient's condition improved.There was no indication that the infection was related to the cardiac stents or procedure.The patient went into ventricular tachycardia cardiac arrest.Resuscitation attempts were unsuccessful and the patient died on (b)(6) 2018.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).Correction: date of death.
Event or Problem Description
Subsequent to the initial 30-day medwatch report, the following information was received: date of death: (b)(6) 2018.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 7749051
• Report Number: 2024168-2018-06023
• Device Sequence Number: 1793491
• Product Code: NIQ
• UDI-Device Identifier: 08717648199295
• UDI-Public: 08717648199295
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 10/23/2020
• Device Catalogue Number: 1125275-33
• Device Lot Number: 7101241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 04/01/2019
• 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: 3.0X12MM XIENCE ALPINE
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 122