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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 UNK XIENCE SKYPOINT
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  Injury  
Event Description
It was reported in a general comment that the physicians are not satisfied with the performance of the xience skypoint and the radial force is not strong enough needing to perform additional post dilatation at higher pressures. There was no adverse patient (b)(6) and there was no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
Date of event has been estimated. The unique device identifier (udi) is unknown because the part number and lot number were not provided. Implant date has been estimated. The device was not returned for evaluation. A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis. The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition); however, the subsequent treatment appears to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling. Na.
 
Manufacturer Narrative
Date of event has been estimated. The unique device identifier (udi) is unknown because the part number and lot number were not provided. Implant date has been estimated. The device was not returned for evaluation. A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis. The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition); however, the subsequent treatment appears to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported in a general comment that the physicians are not satisfied with the performance of the xience skypoint and the radial force is not strong enough needing to perform additional post dilatation at higher pressures. There was no adverse patient sequela and there was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameXIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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 Key13536458
MDR Text Key285635289
Report Number2024168-2022-01560
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeSP
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
Type of Report Initial
Report Date 02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK XIENCE SKYPOINT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/15/2022 Patient Sequence Number: 1
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