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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
Model Number 1804350-23
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  Injury  
Event Description
It was reported in an article that a 3. 5x23mm xience skypoint stent delivery system (sds) was successfully implanted from the mid left main trunk (lmt) to the proximal left anterior descending (lad) artery, crossing over the left circumflex (lcx). After stent implantation, a proximal optimization technique (pot) was performed to fully appose the proximal part of the stent in the lmt. It was then followed with the proximal balloon edge dilation technique. Details are listed in the article, "bifurcation percutaneous coronary intervention of left main trunk treated using a proximal optimizing technique and proximal balloon edge dilation technique".
 
Manufacturer Narrative
Date of event has been estimated. Date of implant has been estimated. The device was not returned for analysis. A review of the electronic lot history record (elhr) and similar incident query for this product were not performed because the lot number was not reported and the product was not returned for analysis. The investigation determined a conclusive cause for the reported patient-device incompatibility (wall apposition) cannot be determined. The 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. Literature article titled ¿bifurcation percutaneous coronary intervention of left main trunk treated using a proximal optimizing technique and proximal balloon edge dilation technique. ¿.
 
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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 Key13578754
MDR Text Key285956017
Report Number2024168-2022-01848
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648233418
UDI-Public08717648233418
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 Literature
Reporter Occupation
Type of Report Initial
Report Date 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1804350-23
Device Catalogue Number1804350-23
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/29/2022
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: 02/22/2022 Patient Sequence Number: 1
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