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

Model Number 1550325-12

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

Patient Problems Angina (1710); Death (1802); High Blood Pressure/ Hypertension (1908); Heart Failure (2206)

Event Date 06/29/2020

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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of hypertension, death and angina are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that on (b)(6) 2020 the 3.25x12 mm xience sierra stent was implanted in this patient who had a non st elevation myocardial infarction (nstemi).On (b)(6) 2020 the patient was re-admitted to the hospital with hypertensive heart, chronic kidney disease with heart failure (stage 5 end stage renal disease).The patient had chest pain.The patient was treated with urinary filtration and discharged to home health on (b)(6) 2020.On (b)(6) 2020 the patient was re-admitted to the hospital with acute respiratory failure with hypoxia.The patient had chest discomfort.The patient was placed on respiratory ventilation until the patient expired on (b)(6) 2020.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10976569
• MDR Text Key: 220463170
• Report Number: 2024168-2020-10327
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227325
• UDI-Public: 08717648227325
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2021
• Device Model Number: 1550325-12
• Device Catalogue Number: 1550325-12
• Device Lot Number: 0012941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR