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

Model Number	10605
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Leak/Splash (1354); Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Codes	Occlusion (1984); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.Vascular access was obtained via right femoral artery.The target lesion was located in the moderately tortuous mid left anterior descending artery.A 3.00 x 28 synergy drug-eluting stent was advanced but was undeployed.The device was removed intact over the wire from the patient's body.The stent was advanced again twice but still failed to deploy and was removed.On the fourth attempt, the stent balloon was advanced and was inflated to 7 atmospheres for 11 seconds but lost pressure and was not able to be retrieved from the guide catheter.The distal shaft, including the stent and balloon was left in the artery.The patient underwent cabg surgery and removal of the remaining stent system.The device was removed intact from the patient's body and it was noticed that the catheter was broken.The procedure was completed.No patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.Vascular access was obtained via right femoral artery.The target lesion was located in the moderately tortuous mid left anterior descending artery.A 3.00 x 28 synergy drug-eluting stent was advanced but was undeployed.The device was removed intact over the wire from the patient's body.The stent was advanced again twice but still failed to deploy and was removed.On the fourth attempt, the stent balloon was advanced and was inflated to 7 atmospheres for 11 seconds but lost pressure and was not able to be retrieved from the guide catheter.The distal shaft, including the stent and balloon was left in the artery.The patient underwent cabg surgery and removal of the remaining stent system.The device was removed intact from the patient's body and it was noticed that the catheter was broken.The procedure was completed.No patient complications reported and the patient's status was stable.It was further reported that when the broken shaft was left in the artery it caused an acute occlusion requiring the surgery.Six days later, the patient was discharged in stable condition.It was further reported that the target lesion was moderately angulated and moderately calcified.The lesion was pre-dilated with several emerge balloons.During the fourth attempt to advance the stent, the shaft was kinked inside the guide catheter.The physician tried to remove the device but when that failed, an attempt was made to inflate the stent balloon.Only a small amount of contrast reached the balloon catheter and the ends of the stent started to deploy.The balloon pressure dropped and on deflation, blood returned to the inflation device.It was noted that the shaft was broken inside the guide catheter, about 30 cm from the end of the catheter.The physician stated that shaft was fractured due to excessive force applied upon multiple insertions of the device.It as further reported that this event was reported in duplicate under emdr 2134265-2020-14032.

• 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: 10648335
• Report Number: 2134265-2020-13313
• Device Sequence Number: 14281946
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: 08714729840299
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 03/10/2022
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0025403037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 10/18/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 87 YR