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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; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1120250-23
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2022
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a de novo lesion in the right coronary artery (rca) with 60% stenosis.The 2.5x23mm xience alpine stent delivery system (sds) was advanced without resistance and failed to cross due to the anatomy, however, the extraction system separated in the guide wire exit port area and the stent dislodged but was retrieved inside the anatomy using a retriever.A second same size xience alpine sds resulted in the same issue.There was no resistance during removal.There was no resistance noted before the dislodgement for the first 2 xience alpine stents that dislodged.A third same size xience alpine sds was inflated once at 8 atmospheres (atms) and was successfully implanted, however, the balloon failed to deflate and was removed inflated.There was no difficulty removing the stylet or protective sheath and the device was prepared (air aspiration) outside the anatomy prior to use.There was no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The delivery system is returning and the stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional xience alpine stent delivery systems referenced are being filed under separate medwatch report numbers.
 
Event Description
It was reported that the procedure was to treat a de novo lesion in the right coronary artery (rca) with 60% stenosis.The 2.5x23mm xience alpine stent delivery system (sds) was advanced without resistance and failed to cross due to the anatomy, however, the extraction system separated in the guide wire exit port area and the stent dislodged but was retrieved inside the anatomy using a retriever.A second same size xience alpine sds resulted in the same issue.There was no resistance during removal.A third same size xience alpine sds was successfully implanted, however, the balloon only partially deflated and was removed inflated.There was no difficulty removing the stylet or protective sheath and the device was prepared (air aspiration) outside the anatomy prior to use.There was no adverse patient sequela and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: there was no resistance noted before the dislodgement for the first 2 xience alpine stents that dislodged.The contrast medium for the third xience alpine sds was diluted 1:1 with normal saline and contrast and was inflated once at 8 atmospheres (atms), however, failed to deflate completely.No additional information was provided.
 
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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported deflation problem.Factors that may contribute to a partially deflated balloon post deployment include, but are not limited to, contrast mixture, contamination in the inflation lumen, damage to the inflation lumen, deflation technique, and/or loose connection with the indeflator.There was no damage noted to the stent delivery system during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported deflation problem.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9/h3: return status - device will not be returned.
 
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Brand Name
XIENCE ALPINE 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 Key16125355
MDR Text Key306982145
Report Number2024168-2023-00305
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeRS
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 Physician
Type of Report Initial,Followup
Report Date 02/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1120250-23
Device Lot Number2042941
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/21/2022
Initial Date FDA Received01/09/2023
Supplement Dates Manufacturer Received02/02/2023
Supplement Dates FDA Received02/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age65 YR
Patient SexMale
Patient Weight39 KG
Patient RaceWhite
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