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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1550300-28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Myocardial Infarction (1969); Tachycardia (2095); Ventricular Fibrillation (2130); Stenosis (2263); Prolapse (2475)
Event Date 06/03/2019
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. It should be noted that the reported patient effect(s) of myocardial infarction, ventricular arrhythmias, stenosis, prolapse and angina are listed in the xience sierra everolimus eluting coronary stent system instructions for use as a known patient effect(s) of coronary procedures. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined. Based on the information reviewed, 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 presented with silent ischemia and severe calcification within the proximal circumflex (cx) coronary artery, 75% stenosed lesion. Atherectomy was performed and a 2. 75x33mm (1550275-33, 8080241) and 3. 0x28mm (1550300-28, 8080941) xience sierra stents were implanted in the cx with acceptable results. Post-implantation, intra-stent plaque protrusion was observed with the 3. 0x28mm xience sierra stent. Additional balloon dilatation was performed. On (b)(6) 2020, the patient was admitted to the hospital with chest pain, elevated troponin, and a non-st elevated myocardial inflation (nstemi) was diagnosed. Medication had been taken prior and a heparin drip was initiated. The patient went into ventricular tachycardia/ventricular fibrillation arrest. Cardiopulmonary resuscitation was performed and cardioversion shocks were provided two times. On (b)(6) 2020, the proximal cx, 3. 0x28mm xience sierra stent, was observed with 90% occlusion, in-stent restenosis within the proximal 5mm of the stent. As treatment, another stent was implanted. The event resolved. There was no device malfunction. No additional information was provided regarding this issue.
 
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Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
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 Key10537644
MDR Text Key207118382
Report Number2024168-2020-07733
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
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 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/22/2019
Device Model Number1550300-28
Device Catalogue Number1550300-28
Device Lot Number8080941
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 Received08/26/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/15/2020 Patient Sequence Number: 1
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