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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 1070350-23
Device Problems Unintended System Motion (1430); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2021
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 investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified, moderately tortuous and 85% stenosed anatomy resulting in the reported difficult to advance. Interaction/ manipulation of the device resulted in compromising the stent such that during inflation ultimately resulted in the reported unintended system motion (stent dislodged during inflation). The treatment appears to be related to the operational context of the procedure as a 3. 5x23mm xience xpedition stent was implanted over the first stent, which was at least partially in the target lesion. There is no indication of a product quality issue with respect to manufacture, design or labeling. Na.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the heavily calcified, moderately tortuous, 85% stenosed proximal left anterior descending coronary artery. After facing resistance with the anatomy, a 3. 5x23mm xience xpedition stent dislodged during inflation, so a 3. 5x23mm xience xpedition stent was implanted over the first stent, which was at least partially in the target lesion. 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 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 Key11396231
MDR Text Key234199334
Report Number2024168-2021-01579
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,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1070350-23
Device Lot Number0022641
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 Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/01/2021 Patient Sequence Number: 1
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