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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
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ABBOTT VASCULAR XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1011711-28
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270); Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 a de novo, moderately calcified and heavily tortuous vessel in the left anterior descending (lad) artery.The 4.0x28mm xience prime stent delivery system (sds) balloon was inflated once at 10 atmospheres (atms) with a contrast mix of 1:1 heparinized normal saline and the stent was deployed, however, the balloon completely failed to deflate post implantation even after negative was held for 5 seconds.The balloon was withdrawn inflated and there was resistance with the anatomy during removal.Force was applied during removal and after several attempts, the balloon was pulled along with the guiding catheter.No additional intervention was required, the catheter was removed together with guiding catheter that was already present in the anatomy.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
A visual, dimensional, and functional inspection were performed on the returned device.The reported failure to deflate and activation failure including expansion failures could not be confirmed.The reported difficult to remove could not be tested as it was based on operational context.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.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.H6: medical device problem code 1149 and 2017 removed; 4060 added.
 
Event Description
It was reported that the procedure was to treat a de novo, moderately calcified and heavily tortuous vessel in the left anterior descending (lad) artery.The 4.0x28mm xience prime stent delivery system (sds) balloon was inflated once at 10 atmospheres (atms) with a contrast mix of 1:1 heparinized normal saline and the stent was deployed, however, the balloon completely failed to deflate post implantation even after negative was held for 5 seconds.The balloon was withdrawn inflated and there was resistance with the anatomy during removal.Force was applied during removal and after several attempts, the balloon was pulled along with the guiding catheter.No additional intervention was required, the catheter was removed together with guiding catheter that was already present in the anatomy.There was no adverse patient effect and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the stent failed to deploy.The balloon held negative for 15 seconds to deflate the balloon but failed to deflate and the sds had to be pulled back along with the stent.No additional information was provided.
 
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Brand Name
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of Device
DRUG 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 Key13793343
MDR Text Key287677197
Report Number2024168-2022-02733
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 Physician
Type of Report Initial,Followup
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1011711-28
Device Lot Number1062241
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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