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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number UNK XIENCE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Angina (1710)
Event Date 03/26/2022
Event Type  Injury  
Manufacturer Narrative
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 part and lot numbers were not provided. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported treatments appear 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; therefore, no product-related corrective action will be implemented in this case.
 
Event Description
It was reported the first procedure was on (b)(6) 2022, a non-abbott stent was implanted in the obtuse marginal and an abbott stent (stent name/size not provided) was implanted in the right coronary artery. After the first procedure, on (b)(6) 2022 (estimated date, date not provided), the patient experienced chest pain. On (b)(6) 2022, a second procedure was performed. Four unknown stents were implanted. The patient continues to have chest pain. No additional information was provided.
 
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Brand NameXIENCE 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 Key14108052
MDR Text Key289254892
Report Number2024168-2022-04035
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P070015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK XIENCE
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/13/2022 Patient Sequence Number: 1
Treatment
STENT: RESOLUTE ONYX
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