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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1070275-48
Device Problems Unintended System Motion (1430); Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
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. As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the mildly tortuous, heavily calcified and 85% stenosed anatomy resulted in compromising the stent such that during inflation resulted in the reported unintended system motion/stent dislodgement; thus resulting in the reported patient-device incompatibility/stent not fully apposed to the vessel wall. The 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. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was to treat a mildly tortuous, heavily calcified mid left anterior descending artery that was 85% stenosed. When a 2. 75x48mm xience xpedition stent was advanced to the lesion and inflated, it then dislodged only partially covering the target lesion and not fully apposed to the vessel wall. The physician then implanted a same size xience xpedition over the dislodged xience xpedition stent to fully appose it to the vessel wall. An additional stent was also used to cover part of the target lesion that was left uncovered. There was no adverse patient sequela and no clinically significant delay. No additional information was provided.
 
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Brand NameXIENCE XPEDITION 48 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 Key11672095
MDR Text Key245601483
Report Number2024168-2021-03169
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 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/20/2022
Device Catalogue Number1070275-48
Device Lot Number9061241
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 Received04/05/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/15/2021 Patient Sequence Number: 1
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