MAUDE Adverse Event Report: BOSTON SCIENTIFIC SYNERGY; STENT, CORONARY, DRUG

Lot Number 19142188

Device Problems Difficult to Remove (1528); Device Slipped (1584)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/21/2016

Event Type  malfunction  

Event Description

During cardiac catheterization, the stent fell off the delivery system prior to deployment and was unable to retrieve.A foreign body was in the right coronary artery (rca).

• Brand Name: SYNERGY
• Type of Device: STENT, CORONARY, DRUG
• Manufacturer (Section D): BOSTON SCIENTIFIC; two scimed place; maple grove MN 55311
• MDR Report Key: 5972643
• MDR Text Key: 55438592
• Report Number: 5972643
• 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: Other
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 19142188
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 67