MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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. ¿.

• 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 Key: 13578754
• MDR Text Key: 285956017
• Report Number: 2024168-2022-01848
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• 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 Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1804350-23
• Device Catalogue Number: 1804350-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2022
• 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