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

Model Number 10602

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  Injury  

Event Description

It was reported that difficulty deflating, removal difficulties and stent profile problem occurred.The target lesion was located in a coronary artery.A 3.50 x 16mm synergy ii drug-eluting stent was implanted at 20 atmospheres.During deflation the balloon felt sticky and tension was felt while pulling the balloon into the guide catheter.The device was able to be removed; however, the middle of the stent was not uniformly open and the lesion was not allowing it to fulling expand, they were unable to reach the area again to fully expand the device.No patient complications were reported and the patient status was stable.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10478285
• MDR Text Key: 205158908
• Report Number: 2134265-2020-12126
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840121
• UDI-Public: 08714729840121
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024695056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2019
• 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): Other