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

Model Number	10603
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent inadequate apposition occurred.The target lesion was located in the proximal right coronary artery.A 6f non-bsc guide catheter was inserted and a forte mod with markers guide wire was advanced to the lesion.A 4.00 x 20mm synergy ii drug-eluting stent (des) was implanted in the lesion; however, it was noted that the mid portion of the stent was not fully expanded.A 4.00mm x 12mm nc emerge balloon catheter was advanced to post dilate the implanted stent.However, during the fourth inflation at 25 atmospheres after 36 seconds, the balloon ruptured.During removal, the balloon hung up on the proximal edge of the stent.The device was removed together with the forte wire.Once outside of the patient, it was noted that the balloon ruptured horizontally and a portion of the balloon was left inside the patient.On the next contrast injection, there was a slight hazy appearance on the proximal edge of the synergy des.It was suspected to be a portion of the balloon material.A new 4.0x12mm synergy des was advanced and deployed overlapping the proximal portion of the previous implanted stent.The stent balloon was used for post dilation following deployment.Final images showed a good result.No further patient complications were reported and the patient was stable throughout the procedure and returned to the floor post procedure.

• 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: 8351147
• Report Number: 2134265-2019-01190
• Device Sequence Number: 18883556
• Product Code: NIQ
• UDI-Device Identifier: 08714729840190
• UDI-Public: 08714729840190
• 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): 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2020
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0022863085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR