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

Model Number 1550225-38

Device Problems Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems Stenosis (2263); Foreign Body In Patient (2687)

Event Date 10/04/2018

Event Type  malfunction  

Event Description

Per cath report: following advancement of a choice pt wire distally to the left anterior descending (lad) artery, a 2.25 x 15 balloon was used to dilate the mid distal lad where there was 90% stenosis, a 3.0 x 15 was deployed to post dilate the stent.They were unable to pass the stent.So a second wire was placed as a buddy wire.An attempt was made to place a xience sierra 2.25 x 38 drug eluting stent.However, they were unsuccessful as the "stent got caught." they tried to remove the wire and remove the stent from the body however when pulling the wires and stent back, they had great difficulty and when the final guidewire and balloon all came out, it was noted immediately that the stent had become disconnected from the balloon and had appeared to be left within the left coronary artery from the left main extending into the proximal lad (within the previous stents).There was no flow disruption noted.

• Brand Name: XIENCE SIERRA
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 7973185
• MDR Text Key: 124009832
• Report Number: 7973185
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1550225-38
• Device Catalogue Number: 1550225-38
• Device Lot Number: 8080441
• 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: 10/15/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 100