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

Model Number 1550350-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Cardiac Enzyme Elevation (1838); High Blood Pressure/ Hypertension (1908); Ventricular Fibrillation (2130)

Event Date 01/07/2020

Event Type  Death  

Manufacturer Narrative

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 dyspnea, angina and hypertension are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic 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; however, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2019 the 3.5x12 mm xience sierra stent was implanted in the mid left anterior descending (lad) coronary artery.On (b)(6) 2020 the patient had chest pain and shortness of breath.The patient was re-admitted to the hospital and treated with medication.An elevation in troponin was noted.The condition was dealt with as secondary to hypertensive urgency.A coronary angiogram was not performed because of the patient's history of advanced chronic kidney disease.The condition resolved on (b)(6) 2020.On (b)(6) 2020 the patient was re-admitted to the hospital again with shortness of breath and chest pain.The condition is continuing.No additional information was received.

Manufacturer Narrative

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 ventricular fibrillation, stenosis, and death are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic 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 of the device.

Event Description

Patient id: (b)(6).It was reported that on 3/4/2019 the 3.5x12 mm xience sierra stent was implanted in the mid left anterior descending (lad) coronary artery.On (b)(6) 2020 the patient had chest pain and shortness of breath.The patient was re-admitted to the hospital and treated with medication.The condition was dealt with as secondary to hypertensive urgency.A coronary angiogram was not performed because of the patient's history of advanced chronic kidney disease.The condition resolved on (b)(6) 2020.On (b)(6) 2020 the patient was re-admitting again with shortness of breath and chest pain.Subsequent to the previously filed report, additional information was received that on (b)(6) 2020 the patient had unstable angina.Percutaneous coronary intervention was performed on (b)(6) 2020.On (b)(6) 2020 the patient went into ventricular fibrillation/cardiac arrest.Cardio-pulmonary resuscitation was performed and medication was administered.The patient was pronounced dead in the emergency room.No additional information was received.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9666695
• MDR Text Key: 177802785
• Report Number: 2024168-2020-01176
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227400
• UDI-Public: 08717648227400
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2019
• Device Model Number: 1550350-12
• Device Catalogue Number: 1550350-12
• Device Lot Number: 8111541
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 119