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

Model Number 10605

Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Death (1802)

Event Date 12/21/2019

Event Type  Death  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported via medwatch that a shaft break, deflation failure and removal difficulties and a patient death occurred.The target lesion was located in the left circumflex coronary artery(lcx).A 3.00 x 28mm synergy ii drug-eluting stent was advanced for treatment.However, the stent balloon was unable to be removed from the lcx after the stent was deployed.Multiple techniques were tried to use to dislodge the balloon.Eventually, the shaft of the catheter broke at the wire exit site from the monorail catheter.The patient retains the foreign body following procedure and was sent for open heart surgery to try and prevent further injury.However, the patient passed away few days later.

• 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: 9627300
• MDR Text Key: 176246794
• Report Number: 2134265-2020-00401
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: 08714729840299
• 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: 01/24/2020

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: 06/06/2020
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0022236415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• 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): Death