MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number 10602

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent migration occurred.The target lesion with a bend of 90 degrees and located in the circumflex artery.A 2.50 x 16 mm synergy drug-eluting stent was attempted to advance through an under-deployed stent that was implanted 3 months prior to this procedure.The synergy stent could not cross and the stent delivery system was pulled back into the guidezilla ii.The stent embolized inside the patient as it was being pulled back into the guidezilla ii.The physician placed a 2.5 x 20 mm synergy to cover the embolized stent.The procedure was completed by upsizing the guide extension catheter to a 7fr guidezilla ii and balloon dilations were performed.No further patient complications were reported and the patient was fine.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8846921
• MDR Text Key: 152815577
• Report Number: 2134265-2019-08939
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention