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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM CE DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1120400-12
Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 07/03/2020
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 similar incidents from this lot. The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter during advancement causing the reported difficulty to advance and subsequent stent dislodgement with device embedded. 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 performed to treat a moderately calcified, moderately tortuous brachial artery. The 4. 0x12mm xience alpine stent delivery system had mild resistance with the guiding catheter then the stent dislodged. The dislodged stent was crushed into the brachial artery. No other stent was used to treat the lesion. There was no adverse patient sequela reported. No additional information was provided.
 
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Brand NameXIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM CE
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 Key10361586
MDR Text Key201521700
Report Number2024168-2020-06474
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeAS
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 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/25/2021
Device Catalogue Number1120400-12
Device Lot Number8091741
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 Received07/14/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/04/2020 Patient Sequence Number: 1
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