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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 1070350-48
Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/31/2021
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a moderately calcified and moderately tortuous lesion in the left anterior descending (lad) coronary artery. Pre-dilatation was performed using a non-abbott balloon. The 3. 5x48mm xience xpedition stent delivery system (sds) was able to cross the lesion without resistance and the stent was deployed successfully at nominal pressure. There were no deflation issues, however, upon removal of the sds, it was found that the distal tip of the balloon was stuck at the guiding catheter tip. After a few attempts to remove the sds with force applied, it was found that the delivery shaft was broken into 2 separate pieces. The proximal half of the sds was pulled out from the guiding catheter independently. The distal half of the sds was retrieved by pulling the whole guiding catheter system out. There was no adverse patient effect and there was no significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
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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 Key12828536
MDR Text Key280890818
Report Number2024168-2021-10467
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeMY
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,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1070350-48
Device Lot Number1032241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2021
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: 11/17/2021 Patient Sequence Number: 1
Treatment
GUIDING CATHETER
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