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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
Catalog Number 1500250-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Stenosis (2263)
Event Date 06/01/2021
Event Type  Injury  
Manufacturer Narrative
The age and weight were obtained from the index procedure date on (b)(6) 2020.The device was not returned for analysis.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 angina and stenosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect(s) 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 subsequent 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
Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with a recent non-st elevated myocardial infarction (nstemi) and in-stent restenosis in the distal left anterior descending (lad) coronary artery.Pre-dilatation was performed and a 2.5x15mm xience sierra stent was implanted with acceptable results, 0% residual stenosis and no complications.On (b)(6) 2021, the patient was admitted to the hospital with stable angina.Per imaging, severe in-stent restenosis of the target distal lad xience sierra was noted.Another revascularization was performed as treatment.The event resolved without sequela.No additional information was provided regarding this issue.
 
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Brand Name
XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
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 Key12471021
MDR Text Key271458990
Report Number2024168-2021-08155
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeSP
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation Physician
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/03/2022
Device Catalogue Number1500250-15
Device Lot Number9062841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/24/2021
Initial Date FDA Received09/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age50 YR
Patient Weight70
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