MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC SYNERGY XD STENT 3.00MM X 12MM CORONARY DRUG-ELUTING STENT

Model Number H7493941812300

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2022

Event Type  malfunction  

Event Description

During a pci (percutaneous coronary intervention) procedure in the cardiac cath lab the stent came apart from the delivery balloon. It was a suspected supply malfunction. There was no harm to the patient as a balloon that was in place was expanded to protect the distal vessel. Then the guide was advanced to capture the stent. A second balloon was placed in the guide to trap the stent in the guide, and everything was removed as a single unit. New equipment was used to complete the procedure. Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC SYNERGY XD STENT 3.00MM X 12MM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13367176
• MDR Text Key: 284647153
• Report Number: MW5107017
• 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: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: H7493941812300
• Device Catalogue Number: H7493941812300
• Device Lot Number: 28083611
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes