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

Model Number	10607
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that balloon deflation slow and difficulty removal occurred.The target lesion was located in the right coronary artery.After crossing a non-bsc guide wire, pre-dilatation was performed with a 3x30mm emerge balloon.A 3.50x38mm synergy stent was then deployed.However, it was noted that the balloon deflation was slow but was able to withdraw the balloon system after about 20 seconds.Subsequently, a 3.50x28mm synergy stent was then deployed, overlapping the first stent about 3-4 mm.However, balloon deflation was slow and once it deflated, the stent system could not be removed.The tech pulled negative, a couple times on the balloon system and then went to tug on it the guide did come into the ostium of the vessel a little bit but eventually it was able to be removed.Post-dilatation was performed with a 3.5 x 30 non-bsc balloon and then switched to a 3.5x15 nc emerge balloon was attempted but failed to cross the previously implanted stents.The device was removed and a 3.5x15mm emerge balloon was able to dilate the proximal area of 3.5x25 stent.Further dilatation was performed with a new 4.0x15mm nc emerge balloon and the procedure was completed with good flow and no complications to the patient.

• 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: 8854752
• Report Number: 2134265-2019-09091
• Device Sequence Number: 2499068
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: 08714729840428
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/02/2019

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: 03/25/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0023611668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: RUNTHROUGH
• Patient Age: 63 YR