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

Model Number	10602
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that the balloon burst and the shaft broke.A 3.50 x 16 synergy balloon expandable stent was selected for a percutaneous coronary intervention procedure in the mildly tortuous, mildly calcified right coronary artery (rca).The synergy stent was delivered to the rca.The physician was able to fully deploy the stent, but the delivery balloon burst.During removal, the delivery system was pulled fully into the guide catheter but the shaft broke at the guidewire exchange port.Everything was removed from the patient as one unit.A new guide catheter and balloon were selected to complete the procedure.The patient experienced no complications and is fine.
Additional Manufacturer Narrative
Device is combination product.Device evaluation by mfr: the returned device consisted of a synergy ii 3.50 x 16 mm stent delivery system.The stent was not returned for analysis as the physician was able to fully deploy the stent during the procedure.Visual and functional analysis of the balloon showed that the balloon folds were relaxed and appeared to have been inflated.Blood was identified in the balloon.The device soaked in water bath before inflation.An inflation aid was used to inflate the balloon per directions for use.The balloon inflated without issue and no leaks or ruptures were noted.The balloon deflated within the specifications of the directions for use.A visual and microscopic examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A 0.014 guidewire loaded successfully through the tip and exited the port.A mid- shaft break was identified 119 cm from the distal end of the strain relief.Damage was also observed in the laser cut region 107 cm from the distal end of the strain relief.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the balloon burst and the shaft broke.A 3.50 x 16 synergy balloon expandable stent was selected for a percutaneous coronary intervention procedure in the mildly tortuous, mildly calcified right coronary artery (rca).The synergy stent was delivered to the rca.The physician was able to fully deploy the stent, but the delivery balloon burst.During removal, the delivery system was pulled fully into the guide catheter but the shaft broke at the guidewire exchange port.Everything was removed from the patient as one unit.A new guide catheter and balloon were selected to complete the procedure.The patient experienced no complications and is fine.

• 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: 8658507
• Report Number: 2134265-2019-05941
• Device Sequence Number: 11428741
• Product Code: NIQ
• UDI-Device Identifier: 08714729840121
• UDI-Public: 08714729840121
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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 Expiration Date: 11/25/2020
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0023035748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1