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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 1070300-15
Device Problems Patient-Device Incompatibility (2682); Difficult to Advance (2920)
Patient Problem Intimal Dissection (1333)
Event Date 04/17/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number (b)(4). The stent remains in patient. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the heavily calcified, moderately tortuous, 90% stenosed proximal left anterior descending coronary artery. A 3x15mm xience xpedition stent delivery system (sds) was advanced with resistance due to the anatomy but could only partially cross the lesion. The stent was deployed at a high pressure, and an unspecified balloon dilatation catheter was used to appose the stent to the vessel wall. That is when a dissection was noted, and a new same size xience xpedition was used to successfully cover the dissection. There were no adverse patient sequelae and no clinically significant delay in the procedure. 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 Key8966020
MDR Text Key156633787
Report Number2024168-2019-11478
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/24/2021
Device Catalogue Number1070300-15
Device Lot Number8061441
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 Received10/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2018
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: 09/05/2019 Patient Sequence Number: 1
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