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

Model Number	10605
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred and the patient was sent for surgery.The target lesion was located in the diagonal branch.A 2.25x28mm synergy drug-eluting stent was advanced over the wire.Post stent implantation, the stent delivery system was removed.However, the delivery system broke in half leaving the distal half with the deflated balloon inside the diagonal.The physician tried several techniques to remove the distal delivery system, but after two hours, nothing worked.The patient became unstable and an intra-aortic balloon pump was placed.The patient was emergently sent to open heart surgery to have the device removed.The patient was intubated but doing okay.
Event or Problem Description
It was reported that shaft break occurred and the patient was sent for surgery.The target lesion was located in the diagonal branch.A 2.25x28mm synergy drug-eluting stent was advanced over the wire.Post stent implantation, the stent delivery system was removed.However, the delivery system broke in half leaving the distal half with the deflated balloon inside the diagonal.The physician tried several techniques to remove the distal delivery system, but after two hours, nothing worked.The patient became unstable and an intra-aortic balloon pump was placed.The patient was emergently sent to open heart surgery to have the device removed.The patient was intubated but doing okay.It was further reported that the lesion has 90% stenosis, non tortuous and moderately calcified.A 6 french guide catheter was used during the procedure.The lesion was predilated and there was 20% stenosis after dilatation.The physician waited for 60 seconds for balloon deflation before pulling back.The absence of contract was confirmed within the balloon under fluoroscopy.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy ii us mr 2.25 x 28mm stent delivery system was returned for analysis.The device was returned without the stent.The device was returned without the balloon section of the device.The device was returned without the balloon and tip sections of the device.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found a break in the shaft polymer extrussion located at the port bond with the core wire exposed.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred and the patient was sent for surgery.The target lesion was located in the diagonal branch.A 2.25x28mm synergy drug-eluting stent was advanced over the wire.Post stent implantation, the stent delivery system was removed.However, the delivery system broke in half leaving the distal half with the deflated balloon inside the diagonal.The physician tried several techniques to remove the distal delivery system, but after two hours, nothing worked.The patient became unstable and an intra-aortic balloon pump was placed.The patient was emergently sent to open heart surgery to have the device removed.The patient was intubated but doing okay.It was further reported that the lesion has 90% stenosis, non tortuous and moderately calcified.A 6 french guide catheter was used during the procedure.The lesion was predilated and there was 20% stenosis after dilatation.The physician waited for 60 seconds for balloon deflation before pulling back.The absence of contract was confirmed within the balloon under fluoroscopy.

• 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: 10810155
• Report Number: 2134265-2020-15357
• Device Sequence Number: 4177450
• Product Code: NIQ
• UDI-Device Identifier: 08714729840268
• UDI-Public: 08714729840268
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2021

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: 01/21/2022
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0025136952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/20/2020; 12/22/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/07/2020; 01/07/2021
• 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: Required Intervention
• Patient Age: 81 YR