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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1011709-33
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. It was reported that negative pressure was held for 5 seconds prior to retracting into the guide catheter. It should be noted in the xience prime everolimus eluting coronary stent system (eecss), instructions for use (ifu) specifies: deflate the balloon by pulling negative on the inflation device. Larger and longer balloons will take more time (up to 30 seconds) to deflate than smaller and shorter balloons. Confirm balloon deflation under fluoroscopy and wait 10 ¿ 15 seconds longer. It is unknown if the ifu deviation contributed to the reported event. The investigation was unable to determine a conclusive cause for the reported difficulties. 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 to treat a moderately calcified, heavily tortuous, de novo lesion in the left anterior descending (lad) artery. A 3x33mm xience prime drug eluting stent (des) was advanced to the target lesion and implanted without issue with one inflation at 10 atmospheres (atm). During removal, negative pressure was held for 5 seconds, however the balloon failed to deflate and was removed fully inflated from the anatomy with difficulty. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameXIENCE PRIME LL 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 Key13811861
MDR Text Key287585114
Report Number2024168-2022-02840
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1011709-33
Device Lot Number1042141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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