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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 1550350-38
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Stenosis (2263)
Event Date 08/03/2021
Event Type  Injury  
Manufacturer Narrative
The device will not be returned for evaluation as the stent remains in patient.The reported patient effects of angina and stenosis are listed in the xience sierra, everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, 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.The 3 additional xience sierra stents referenced are being filed under separate medwatch report numbers.
 
Event Description
Patient id: (b)(6).It was reported that on (b)(6) 2019 five xience sierra stents were implanted.One 3.5x38 stent in the first obtuse marginal (om1), one 3.5x18 in the right posterior atrio-ventricular (rpav), and three (2.5x38, two 3.0x38) in the right coronary artery (rca).On (b)(6) 2021 the patient had increasing frequency of angina at rest and had a positive stress test.Coronary angiogram showed stenosis in the om1, rca, and left circumflex coronary artery.There was no stenosis in the rpav.The patient was referred for coronary artery bypass graft surgery.No additional information was provided.
 
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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 Key12371732
MDR Text Key268284322
Report Number2024168-2021-07551
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648227462
UDI-Public08717648227462
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 Physician
Type of Report Initial
Report Date 08/26/2021
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 Date06/17/2020
Device Model Number1550350-38
Device Catalogue Number1550350-38
Device Lot Number9061241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/05/2021
Initial Date FDA Received08/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
XIENCE SIERRA STENTS: 3.5X18, 2.5X38, TWO 3.0X38
Patient Outcome(s) Other;
Patient Age47 YR
Patient Weight86
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