MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number	1550300-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Neurological Deficit/Dysfunction (1982); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Respiratory Failure (2484)
Date of Event	09/22/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device remains in the patient.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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of death and cardiac arrest are listed in the xience sierra, everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2019 the 3.0x23 xience sierra stent was implanted in the distal left circumflex coronary artery and the 2.25x18 xience sierra stent was implanted in the first diagonal coronary artery.On (b)(6) 2019 the patient was in cardiac arrest and emergency response arrived.The patient was successfully resuscitated and the patient was transported to the hospital where ventricular tachycardia occurred.The patient was defibrillated several times.On (b)(6) 2019 the patient had acute metabolic encephalopathy related to the cardiac arrest.The patient was intubated and re-warmed for hypothermia.On (b)(6) 2019 hemodialysis was performed for chronic kidney disease, stage 4.On (b)(6) 2019 the patient's ventricular irritability progressed to ventricular fibrillation/arrest and the patient expired.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9483833
• Report Number: 2024168-2019-14646
• Device Sequence Number: 16490073
• Product Code: NIQ
• UDI-Device Identifier: 08717648227271
• UDI-Public: 08717648227271
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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 Catalogue Number: 1550300-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/17/2019
• 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: XIENCE SIERRA STENT 2.25X18 MM
• Outcome Attributed to Adverse Event: Death
• Patient Age: 63 YR
• Patient Weight: 83