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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 1804250-33
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/10/2024
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation.The electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.A conclusive cause for the reported difficulties could not be determined.Factors that could contribute to material deformation include, but are not limited to, damage during manufacturing, inadvertent mishandling during sheath/stylet removal, unpackaging, preparation, or during use of the device, interaction with accessory devices, patient anatomical morphology, or patient disease state.Factors that may contribute to an activation failure including expansion failures include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, it is possible that a loose connection with the indeflator may have contributed to the reported activation failure including expansion failures.Further interaction with the moderately calcified, moderately tortuous anatomy may have contributed to the reported material deformation; however, this cannot be confirmed.Based on the information provided and without the device to examine, a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.
 
Event Description
It was reported that the procedure was to treat a lesion in the proximal to mid left anterior descending (lad) artery with moderate calcification and moderate tortuosity.The 2.5x33mm xience skypoint stent delivery system (sds) was advanced to the lesion; however, the stent was only partially deployed and material deformation [mangled] was noted.The xience skypoint stent and delivery system were removed.A balloon dilatation catheter (bdc) was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.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 Key19169258
MDR Text Key340899604
Report Number2024168-2024-05031
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648233111
UDI-Public(01)08717648233111(17)250620(10)2061641
Combination Product (y/n)Y
Reporter Country CodeJA
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
Report Date 04/23/2024
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 Number1804250-33
Device Lot Number2061641
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/10/2024
Initial Date FDA Received04/23/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/21/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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