MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number H7493926012400

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 12/07/2016

Event Type  malfunction  

Event Description

Stent was deployed with full balloon inflation but the balloon would not completely withdraw from the stent.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 5905 nathan lane; plymouth MN 55442
• MDR Report Key: 6894157
• MDR Text Key: 87372850
• Report Number: 6894157
• 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: 12/20/2016,09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: H7493926012400
• Device Catalogue Number: H7493926012400
• Device Lot Number: 19672342
• 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: 12/20/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES.
• Patient Age: 60 YR