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

Model Number	10605
Medical Device Problem Codes	Break (1069); Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/21/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem 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
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9627300
• Report Number: 2134265-2020-00401
• Device Sequence Number: 19561627
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: 08714729840299
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death