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

Model Number 1550250-18

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

Patient Problems Stroke/CVA (1770); Death (1802); Dyspnea (1816); Pulmonary Edema (2020); Heart Failure (2206)

Event Date 01/17/2020

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.It should be noted that the reported patient effects of cerebrovascular accident, death, dyspnea and pulmonary edema 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 effect(s), and the relationship to the product, if any, cannot be determined; however, the reported 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 of the device.

Event Description

Patient id: (b)(6).On (b)(6) 2020, the patient presented with elevated cardiac enzymes and a percutaneous coronary intervention was performed on the mid left anterior descending (lad) coronary artery, 80% stenosed lesion.A 2.5x18mm xience sierra stent (1550250-18, 9090341) was successfully implanted in the mid lad.Reportedly, there was timi flow 3, 0% stenosis, and there were no procedural complications.That same day, the patient experienced progressive shortness of breath.Blood oxygen was at 78%, electrocardiogram showed normal sinus rhythm, and a chest x-ray showed fluffy, diffuse infiltrates.Medications were provided as a concern for congestive heart failure (chf).The patient had gone into septic shock related to pre-existing pyelonephritis/cholecystitis.On (b)(6) 2020, a blood transfusion had been provided.On (b)(6) 2020, a large left middle cerebral artery (mca) ischemic stroke was observed per imaging.On (b)(6) 2020 a bubble study, ct of the head, and a 2d echocardiogram was performed.Per imaging, there was no evidence of a cardiac etiology embolism.Per neurology, the stroke was either due to hypoperfusion or embolic (of a non-cardiac source per cardiologist).On (b)(6) 2020, the patient expired.Reportedly, this event led to the patient's death.Per physician, the events, including stroke and patient death, were unrelated to the xience sierra device and unrelated to the index procedure.Per physician, the xience sierra stent remained patent as there were no electrocardiogram (ekg) changes.There was no device malfunction and no thrombus observed.No additional information was provided regarding this issue.

• 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: 9721950
• MDR Text Key: 179801614
• Report Number: 2024168-2020-01581
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227103
• UDI-Public: 08717648227103
• Combination Product (y/n): N
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2020
• Device Model Number: 1550250-18
• Device Catalogue Number: 1550250-18
• Device Lot Number: 9090341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 90