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

Model Number	10604
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 2.50 x 24 synergy ii drug-eluting stent was advanced but the stent hung up in the guide catheter.When the device was removed, the shaft broke at the monorail junction inside the guide.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.50 x 24 mm stent delivery system was returned for analysis.Only the proximal end of the device was returned, the distal end of the device including the balloon, stent, tip and shaft polymer extrusion was not returned for analysis.The crimped stent was not returned for analysis.The maximum stent profile was within maximum crimped stent profile measurement.A visual and tactile examination of the hypotube found multiple hypotube kinks and a hypotube break.The break point on the hypotube occurred 690mm distal from strain relief.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 2.50 x 24 synergy ii drug-eluting stent was advanced but the stent hung up in the guide catheter.When the device was removed, the shaft broke at the monorail junction inside the guide.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient was 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: 9236641
• Report Number: 2134265-2019-12669
• Device Sequence Number: 163628
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/04/2019

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 Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0023194057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR