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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 Material Separation (1562); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2022
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat the right coronary artery (rca). A first stent was successfully deployed, however, while the 2. 75x48mm xience xpedition stent delivery system (sds) had no resistance during advancement the physician could not release the stent and it only partially deployed. Upon removal, the sds was observed to have separated. There was no resistance during removal. A catheter was advanced and managed to retrieve the other parts of the sds. There were no pieces of the device left in the anatomy. Another xience xpedition stent was used to complete the procedure. There was no adverse patient effect and there was no clinically significant delay in the procedure. 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 Key14672334
MDR Text Key294860420
Report Number2024168-2022-06295
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCO
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1070275-48
Device Lot Number1111741
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2021
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: 06/12/2022 Patient Sequence Number: 1
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