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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
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ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1800250-48
Device Problems Break (1069); Material Separation (1562); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2022
Event Type  Injury  
Event Description
It was reported that the 2.5x48mm xience skypoint stent delivery system (sds) failed to cross the lesion due to anatomy.During removal of the sds, the distal portion of the sds fractured [break].Another 2.25x38mm xience stent was used to successfully complete the procedure.There was no adverse patient effect reported and no clinically significant delay reported.No additional information was provided.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
The device was returned for analysis.The reported material separation was confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 anatomy causing the reported failure to advance.Continued handling and/or manipulation of the device during removal caused the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.B1: updated to product problem and adverse event.B2: updated to required intervention.B5: additional information.H1: updated to serious injury.H6: medical device problem code 1069 and 2199 were removed.H6: medical device problem code 1562 and 4641 added.
 
Event Description
It was reported that the 2.5x48mm xience skypoint stent delivery system (sds) failed to cross the lesion due to anatomy.During removal of the sds, the distal portion of the sds fractured [break].Another 2.25x38mm xience stent was used to successfully complete the procedure.There was no adverse patient effect reported and no clinically significant delay reported.Subsequently, after the initial report was filed and device analysis was complete, the account confirmed the 2.5x48mm xience skypoint stent separated into two pieces.The separated portion was removed via snare with a lasso catheter.No additional information was provided.
 
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Brand Name
XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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 Key14595155
MDR Text Key293353607
Report Number2024168-2022-05949
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeFR
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 07/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1800250-48
Device Lot Number2020941
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2022
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 Outcome(s) Required Intervention;
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