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

Model Number	10605
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that balloon detachment occured.A 4.00 x 28 synergy stent was advanced for treatment.However, after the stent was deployed and during the removal of stent delivery system the balloon separated from the stent shaft.The physician was able to remove the guide catheter and all the components of the stent delivery system came out with the guide catheter.The procedure was competed with no patient complications.
Event or Problem Description
It was reported that balloon detachment occured.A 4.00 x 28 synergy stent was advanced for treatment.However, after the stent was deployed and during the removal of stent delivery system the balloon separated from the stent shaft.The physician was able to remove the guide catheter and all the components of the stent delivery system came out with the guide catheter.The procedure was competed with no patient complications.
Additional Manufacturer Narrative
Device is combination product.Device evaluated by mfr.: synergy ii us mr 4.00 x 28 mm stent delivery system (sds) was returned for analysis.No stent was returned for analysis as it was deployed in the patient as per complaint report.The balloon body was reviewed, and no issues were noted on the balloon.The balloon wings were relaxed, and the balloon appeared flat, this is consistent with device use.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination found no issues.A visual and tactile examination of the outer and mid-shaft section found a shaft polymer extrusion break at the guidewire exchange port exposing the core wire, the extrusion shaft was stretched distal to the guidewire exchange port.The type of damage noted most likely occurred due to excessive forces that could have been applied on the delivery system.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: 8327764
• Report Number: 2134265-2019-01094
• Device Sequence Number: 10798006
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: 08714729840312
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/04/2019

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: 06/17/2020
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0022304427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1