MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY 3.5 X 12 MONORAIL; CORONARY DRUG-ELUTING STENT

Model Number H7493926012350

Device Problems Retraction Problem (1536); Failure to Advance (2524); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2019

Event Type  malfunction  

Event Description

A boston synergy 3.5 x 12 monrail coronary stent was advanced into the patient's circumflex artery over a 180cm run-through guidewire.The stent catheter would not cross the lesion.A second run-through guidewire was added as a "buddy wire" and an attempt was made to cross the lesion.The stent catheter was removed intact over the wire and placed off to the side.It did not coil or re-hoop but just laid out straight on the table.A 6fr guide liner was inserted for more support.The "buddy wire" was removed ant the stent catheter loaded back into the run-through guide wire.As the physician was advancing the catheter he noticed the shaft of the catheter didn't look right so he asked for a new stent.He then began to removed the stent over the wire.As he was removing the stent, the distal 60% of the stent shaft separated from the rest of the catheter, leaving approximately 40% in the patient with about 12 inches sticking out of the hub of the access sheath.The physician was able to remove the remaining portion of the stent catheter completely intact and it was bagged and given to risk management.A new stent was opened and successfully deployed.No harm was done to the patient.

• Brand Name: SYNERGY 3.5 X 12 MONORAIL
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9134375
• MDR Text Key: 160534924
• Report Number: 9134375
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493926012350
• Device Catalogue Number: H7493926012350
• Device Lot Number: 22705530
• 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: 09/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA