MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SIERRA; CORONARY DRUG-ELUTING STENT

Model Number 1550350-15

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981); Positioning Problem (3009); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Perforation (2001); Stenosis (2263)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

Three devices failed.Incident description: opened, prepped, and advanced three stent catheters.Unable to advance to lesion site in the mid circumflex artery.Removed over wire and all three stents had damage to the stent struts.There were no complications.From the procedural note: intervention: for purpose of intervention, i ultimately upsized to a 7-french system for complex bifurcation intervention.I initially started with a 6-french, and crossed into the first marginal and into the distal av circumflex, after achieving an act (activated clotting time) greater than 300 seconds with a ____ and a pilot wire.A predilation was initially performed into the main av groove circumflex with a 3.0x12 mm balloon.Initial plan given the anatomic configuration was to perform simultaneous stenting with a "pair of pants" anatomic configuration.Unfortunately, given that the 2 wires repetitively became twisted and on top of each other, it did not allow passage of the second stent down the vessel.I had to utilize several different stents and repositioned wires on multiple occasions to attempt to address the issue with switching out, which then we delivered first into the av groove circumflex, the first marginal and neither were successful.I upsized to a 7-french system and additionally tried the same thing with a 7-french cls 3.5 guiding catheter to assess whether there it was guide catheter size related issue.The same issue was involved with wires twisting upon each other.At this point, several stents were unable to pass for this reason, as they could not pass through the guiding catheter, even despite upsizing to a 7-french system.At this point, i elected to simplify the procedure and proceed with stenting of the main branch and balloon angioplasty of the side branch.At this point, utilizing 2 pilot wires, which were placed distally, i stented the main branch with a 3.5x18 mm xience alpine sierra drug-eluting prosthesis, and then re-crossed with a pilot wire into the first marginal branch.I then performed simultaneous kissing balloon angioplasty with a 2.75 mm balloon in the side branch with a 4.0 mm balloon in the main branch.The final result was excellent.There was brisk flow into the av groove circumflex with kissing balloon angioplasty.There was a residual, less than 50% stenosis within the first obtuse marginal.Despite multiple passes of balloon, stents, wires, and different guiding catheter, the left main did not appear different at the end of procedure, and there was no evidence of any distal perforation or distal compromise, despite extensive wire exchanges.

• Brand Name: XIENCE SIERRA
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 11087020
• MDR Text Key: 224081187
• Report Number: 11087020
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227417
• UDI-Public: (01)08717648227417(17)220116(10)0070242(91)5716
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/10/2020

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: No Information
• Device Model Number: 1550350-15
• Device Catalogue Number: 1550350-15
• Device Lot Number: 0070242
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 134