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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1070350-28
Device Problems Unintended System Motion (1430); Patient-Device Incompatibility (2682)
Patient Problem Vascular Dissection (3160)
Event Date 09/22/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents from this lot. The reported patient effect of dissection is listed in the xience everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures. It is possible that during inflation interaction with the mildly tortuous and 90% stenosed anatomy resulted in the reported difficulties; however this cannot be confirmed. The investigation determined a conclusive cause for the reported difficulties cannot be determined. The patient effect of dissection and treatment appears to be related to the operational context of the procedure as the physician implanted a same size xience xpedition over the dislodged xience xpedition stent to fully appose it to the vessel wall, treat the dissection and cover the rest of the untreated part of the target lesion. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a mildly tortuous left anterior descending artery that was 90% stenosed. After advancement of a 3. 5x28mm xience xpedition stent to the lesion, during inflation for deployment, the stent shifted only partially covering the target lesion and not fully apposed to the vessel wall. Additionally, the vessel was noted as dissected. The physician then implanted a same size xience xpedition over the previous xience xpedition stent to fully appose it to the vessel wall, treat the dissection and cover the rest of the untreated part of the target lesion. There was no adverse patient sequela and no clinically significant delay. No additional information was provided.
 
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Brand NameXIENCE XPEDITION 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 Key12665409
MDR Text Key277394414
Report Number2024168-2021-09409
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
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
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1070350-28
Device Lot Number0061741
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 Received10/01/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/20/2021 Patient Sequence Number: 1
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