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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1550275-15
Device Problems Entrapment of Device (1212); Unintended System Motion (1430); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2021
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 interaction with the mildly calcified anatomy and/or inadvertent mishandling resulted in the reported unintended system motion (stent delivery system jumped back). During withdrawal, interaction with the guiding catheter resulted in the reported stent dislodgement. The treatment appears to be related to the operational context of the procedure as reportedly an attempt was made to snare the stent; however, the stent could not be snared through the sheath. Everything was pulled out, except the stent, snare, and wire. It was noted that the stent was stuck in the femoral scar tissue (reported entrapment). Therefore, a surgeon was called and a cut-down was performed. The stent, snare, and wire were retrieved. 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 done to treat a diagonal vessel with mild calcification and no tortuosity. Pre-dilatation was successfully completed with a non-abbott balloon. A 2. 75x15mm xience sierra stent delivery system (sds) was advanced to the target lesion with no issues. However, the physician was about to start deploying the stent when the sds jumped back. The physician was inflating at 2 atms. The inflation was intentionally performed slow. When the sds was being pulled back into the guide, the stent dislodged off the balloon (no resistance was felt when pulling back). This caused a clinically significant delay in the procedure. An attempt was made to snare the stent; however, the stent could not be snared through the sheath. Everything was pulled out, except the stent, snare, and wire. It was noted that the stent was stuck in the femoral scar tissue. Therefore, a surgeon was called and a cut-down was performed. The stent, snare, and wire were retrieved. The patient is stable. The target lesion was not treated. There was no adverse patient sequela reported. No additional information was provided.
 
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Brand NameXIENCE SIERRA 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 Key11423385
MDR Text Key234994283
Report Number2024168-2021-01747
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648227172
UDI-Public08717648227172
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/23/2022
Device Model Number1550275-15
Device Catalogue Number1550275-15
Device Lot Number0081241
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 Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/05/2021 Patient Sequence Number: 1
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