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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 1550300-38
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Atrial Fibrillation (1729)
Event Date 04/10/2020
Event Type  Injury  
Manufacturer Narrative
The reported patient effect(s) of atrial arrhythmias is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures. The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined. However, the 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
It was reported that on (b)(6) 2020 the patient had a 2. 5x38 mm, 3. 00x38 mm and a 3. 50x12 mm xience sierra stent implanted. The patient was discharged and returned on (b)(6) 2020 for paraxysmal atrial fibrillation. Treatment was not specified and final patient outcome is unknown. No additional information was provided.
 
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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 Key10505413
MDR Text Key206090656
Report Number2024168-2020-07481
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/15/2021
Device Model Number1550300-38
Device Catalogue Number1550300-38
Device Lot Number0010841
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 Received09/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/16/2020
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: 09/08/2020 Patient Sequence Number: 1
Treatment
2.50X38 XIENCE SIERRA; 3.50X12 XIENCE SIERRA
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