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

Model Number	10601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of bsc aware date since no event date provided.
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 12mm synergy drug-eluting stent was selected for use.However, the mid shaft broke as it was being advanced through the guide.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 12mm synergy drug-eluting stent was selected for use.However, the mid shaft broke as it was being advanced through the guide.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
B3: date of event - used the first day of the month of bsc aware date since no event date provided.Device evaluated by mfr.: synergy ii us mr 2.25 x 12 mm stent delivery system was returned for analysis broken in the midshaft region of the device and with the distal shaft containing the inner/outer shaft polymer extrusion, bunched balloon, damaged stent and tip stuck on the customer guidewire.The device was returned with the stent damaged on its entire length.Stent struts from the proximal region of the stent were lifted and pulled/bunched in a distal direction.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture.This is within max crimped stent profile measurement.The balloon cones were reviewed, and it was noted that it was bunched proximally.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple hypotube 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 mid shaft region at the guidewire exchange pert as well as multiple stretching and bunching regions of the inner and outer shaft polymer extrusion.No other issues were identified during the product analysis.

• 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: 10735917
• Report Number: 2134265-2020-14361
• Device Sequence Number: 19114517
• Product Code: NIQ
• UDI-Device Identifier: 08714729840022
• UDI-Public: 08714729840022
• 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): 12/07/2020

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 Expiration Date: 02/19/2022
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0025260514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1