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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 1017350-48
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Occlusion (1984)
Event Date 09/04/2019
Event Type  Injury  
Manufacturer Narrative
The stent remains in patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. (b)(4).
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2019, the patient presented with a recent non-st elevated myocardial infarction (nstemi) and with a total occlusion of the heavily calcified proximal left anterior descending (lad) coronary artery. A 3. 5 x 48 mm xience pro stent was implanted. Oct imaging was performed and the proximal and distal stent portion was expanded less than 90%. Balloon dilatation was performed using a non-compliant balloon catheter. Reportedly, >90% expansion was not achieved although the results were clinically acceptable. Following implantation of this stent, the diagonal side branch was lost due to carina shift. Per physician, the event was not serious. There were no clinical symptoms, no angina, and no electrocardiogram (ecg) changes. There was no device malfunction. There was no treatment and the lost branch event resolved. No additional information was provided regarding this issue.
 
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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 Key9188408
MDR Text Key162498455
Report Number2024168-2019-12591
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Catalogue Number1017350-48
Device Lot Number9062441
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 Received10/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2019
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: 10/14/2019 Patient Sequence Number: 1
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