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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
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.
 
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Brand NameXIENCE SIERRA
Type of DeviceDRUG 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 Key9721950
MDR Text Key179801614
Report Number2024168-2020-01581
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
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 Received02/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/17/2020
Device Model Number1550250-18
Device Catalogue Number1550250-18
Device Lot Number9090341
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/18/2020 Patient Sequence Number: 1
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