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

Model Number	10603
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a diagonal branch of the left anterior descending artery.A 2.50x20mm synergy drug eluting stent was advanced through a 6f long guidezilla ii extension catheter to treat the lesion.However, the device failed to cross the lesion and upon removing the device from the guidezilla ii, the stent was noted to be damaged.The procedure was aborted and the physician decided to treat the patient with oral medication for a month.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device is a combination product.The synergy stent delivery system was returned for analysis with a 0.014 guidewire inserted through he port exchange guidewire lumen.An examination (visual and via scope) of the crimped stent found stent damage.The stent was found damaged, dislodged from the balloon and stuck on the guidewire.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within max crimped stent profile measurement.The balloon was reviewed and no signs of positive pressure having been applied to it were noted.The balloon wings were tightly wrapped and folded with crimp markings visible on the exposed balloon body.An examination (visual and via scope) found distal tip damage.A visual and tactile examination of the hypotube found multiple hypotube kinks along several locations 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 no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a diagonal branch of the left anterior descending artery.A 2.50x20mm synergy drug eluting stent was advanced through a 6f long guidezilla ii extension catheter to treat the lesion.However, the device failed to cross the lesion and upon removing the device from the guidezilla ii, the stent was noted to be damaged.The procedure was aborted and the physician decided to treat the patient with oral medication for a month.No patient complications were reported and the patient was fine.It was further reported that the target lesion was 80% stenosed and located in a mildly tortuous and mildly to moderately calcified proximal diagonal.There was a significant bend of approximately 40 degrees.

• 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: 9203094
• Report Number: 2134265-2019-12571
• Device Sequence Number: 449078
• Product Code: NIQ
• UDI-Device Identifier: 08714729840152
• UDI-Public: 08714729840152
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023579041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE EXTENSION CATHETEER: GUIDEZILLA.; GUIDE EXTENSION CATHETEER: GUIDEZILLA.