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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE XPEDITION DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1070300-48
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Cardiac Enzyme Elevation (1838); Ischemia (1942); Myocardial Infarction (1969)
Event Date 03/19/2020
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. The reported patient effects of angina and ischemia are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures. A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. 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 two xience xpedition stents, both 3. 0x48 mm sizes, were implanted in the mid right coronary artery. On (b)(6) 2020 the patient had angina and was admitted to the hospital. There was no change to the electrocardiogram. The troponin levels on (b)(6) 2020 were elevated and were decreasing during the hospitalization. A myocardial perfusion scan possibly indicated the presence of inferior ischemia. Medication was administered, a minitran patch. The condition resolved on (b)(6) 2020. No additional information was provided.
 
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Brand NameXIENCE XPEDITION
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 Key9979426
MDR Text Key189741069
Report Number2024168-2020-03771
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeBE
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/30/2022
Device Catalogue Number1070300-48
Device Lot Number9072241
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 Received08/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2019
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: 04/20/2020 Patient Sequence Number: 1
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