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

Model Number	10606
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that removal difficulties occurred.The target lesion was located in a tortuous mid right coronary artery (rca).Following prediltation of a distal rca lesion, a 3.50 x 32 synergy ii drug eluting stent was introduced but would not advance around the bend at the ostium.An attempt was made to pull the device back into the guide catheter but it would not pull back.The decision was made to deploy the stent where it was in the proximal rca in order to help pull back the device.The stent was deployed at 12 atmospheres with no issues.The stent balloon still would not pull back into the guide catheter until another physician was able to pull back the balloon successfully.No patient complications were reported.

• 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: 9282720
• Report Number: 2134265-2019-13434
• Device Sequence Number: 2388852
• Product Code: NIQ
• UDI-Device Identifier: 08714729840367
• UDI-Public: 08714729840367
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 11/05/2019

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: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0023806200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR