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 Code	Occlusion (1984)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break and vessel occlusion occurred and patient went to surgery.The target lesion was located in the left anterior descending artery (lad).A 3.00 x 28 synergy drug-eluting stent was advanced for treatment; however, during deployment, the balloon failed to inflate and blood was returned when the inflator was deployed.When the device was removed, the stent sheared off and remained in the lad causing an acute occlusion.The patient underwent emergency aortic coronary bypass graft and saphenous vein graft to extended lad arteriotomy to extract the retained stent and balloon.The patient had an uneventful post-operative course and 6 days later, the patient was discharged in stable condition.
Event or Problem Description
It was reported that shaft break and vessel occlusion occurred and patient went to surgery.The target lesion was located in the left anterior descending artery (lad).A 3.00 x 28 synergy drug-eluting stent was advanced for treatment; however, during deployment, the balloon failed to inflate and blood was returned when the inflator was deployed.When the device was removed, the stent sheared off and remained in the lad causing an acute occlusion.The patient underwent emergency aortic coronary bypass graft and saphenous vein graft to extended lad arteriotomy to extract the retained stent and balloon.The patient had an uneventful post-operative course and 6 days later, the patient was discharged in stable condition.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 vascular access was obtained via the right femoral artery.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 was further reported that report is a duplicate of emdr 2134265-2020-13313.

• 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: 10695567
• Report Number: 2134265-2020-14032
• Device Sequence Number: 11689601
• 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: 09/29/2020
• Supplement Date Received by Manufacturer: 10/18/2020
• Initial Report FDA Received Date: 10/19/2020
• 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