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

Model Number	10606
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred which resulted in a surgery.The 95% stenosed target lesion was located in the moderately tortuous and heavily calcified left anterior descending artery (lad).A 3.50 x 32 synergy drug-eluting stent (des) was advanced for treatment but failed to cross the lesion.The device was removed and two 3.50 x 16 synergy des were implanted in the proximal lad.The 3.50 x 32 synergy des was then advanced and crossed the previously implanted stents; however, upon deployment, it stopped inflating at 4 atmospheres.Upon removal, the balloon shaft broke near the hypotube and remained in the body.The patient was sent to a successful bypass surgery the following day and the device was removed.No patient complications were reported and the patient did well.
Additional Manufacturer Narrative
Device evaluation by mfr.: synergy ii us mr 3.50 x 32mm stent delivery system was returned for analysis.The device was returned with a guide catheter with a hemostatic valve and an 0.0140 inch guidewire attached.The distal shaft was not visible.A guidewire passed through the guide catheter multiple times to locate the distal shaft but the distal portion of device did not appear to be inside the guide catheter.The distal section of the device was not returned.A visual and tactile examination of the hypotube found a shaft break 119.5cm distal to the distal end of strain relief as well as multiple severe kinks.The core-wire was exposed at the break site.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred which resulted in a surgery.The 95% stenosed target lesion was located in the moderately tortuous and heavily calcified left anterior descending artery (lad).A 3.50 x 32 synergy drug-eluting stent (des) was advanced for treatment but failed to cross the lesion.The device was removed and two 3.50 x 16 synergy des were implanted in the proximal lad.The 3.50 x 32 synergy des was then advanced and crossed the previously implanted stents; however, upon deployment, it stopped inflating at 4 atmospheres.Upon removal, the balloon shaft broke near the hypotube and remained in the body.The patient was sent to a successful bypass surgery the following day and the device was removed.No patient complications were reported and the patient did well.

• 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: 10934955
• Report Number: 2134265-2020-16580
• Device Sequence Number: 2478265
• Product Code: NIQ
• UDI-Device Identifier: 08714729840367
• UDI-Public: 08714729840367
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/22/2021

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: 02/09/2022
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0025218571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/22/2021
• 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: 78 YR