MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number H7493926032300

Device Problems Break (1069); Detachment Of Device Component (1104); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/09/2017

Event Type  malfunction  

Event Description

Device was inserted into the right coronary artery through the al1.Guide catheter and guidezilla stent would not advance to overlap with previously deployed stent.Device was attempted to be removed.That is when it was noted the stent delivery system shaft had detached from the rest of the device.Many attempts were made to snare the device, but were unsuccessful.Physician decided to jail and crush the stent and leave it inside the body.Manufacturer response for drug eluting stent, des synergy 3.0mmx32mm (per site reporter).Will look into the problem, see why it broke.

• Brand Name: SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 6890352
• MDR Text Key: 87216089
• Report Number: 6890352
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/21/2018
• Device Model Number: H7493926032300
• Device Catalogue Number: H7493926032300
• Device Lot Number: 20838313
• Other Device ID Number: 3.0MMX32MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1