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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 1550325-28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Thrombosis (2100); Dizziness (2194); Stenosis (2263); Prolapse (2475)
Event Date 12/16/2019
Event Type  Injury  
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 myocardial infarction, stenosis, thrombosis and hypotension are listed in the xience sierra everolimus eluting coronary stent systems instructions for use, as a 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. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Patient id (b)(6). It was reported that on (b)(6) 2019, the patient underwent a coronary stenting procedure to treat a lesion in the proximal right coronary artery (rca). A 3. 25 x 28 mm xience sierra stent was implanted without issue. On (b)(6) 2020, the patient presented to the emergency room with lightheadedness and stated they had been feeling weak and lightheaded since the stenting procedure. Additionally, blood pressure was low and cardiac enzymes were elevated. Myocardial infarction was diagnosed. Medications were administered. Cardiology was consulted and angiography was performed, revealing severe in-stent restenosis and thrombosis. Intravenous ultrasound (ivus) noted prolapsed calcific plaque through the stent struts. Revascularization was performed on (b)(6) 2020, with angioplasty, stent implantation and aspiration thrombectomy. The event resolved on (b)(6) 2020. No additional information was provided.
 
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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 Key9624121
MDR Text Key178554396
Report Number2024168-2020-00869
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 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/26/2020
Device Model Number1550325-28
Device Catalogue Number1550325-28
Device Lot Number9041941
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 Received01/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2019
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: 01/23/2020 Patient Sequence Number: 1
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