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

Model Number	10607
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent fracture occurred.The target lesion was located in the right coronary artery.A 3.50x38mm synergy ii drug-eluting stent (des) was deployed for treatment.However, during an intravascular ultrasound, a fracture was noted.The lesion was ballooned and a 35x12mm synergy ii des was successfully deployed.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the device was not returned to the cis for analysis but a single still angiographic image was returned attached to complaint record.The image was reviewed.The image appeared to be a photograph taken of the monitor displaying an angiographic image.The image showed a guide catheter positioned at the right coronary artery (rca) ostium, with contrast flow through the rca.A pacing wire was evident in the heart.A flow narrowing/constriction was noted in the proximal rca.It could not be confirmed in the image if a stent was present or if it was fractured or not.The single angiographic image provided could not be used to confirm or refute the allegation of stent fracture.H3 other text : angiographic image.
Event or Problem Description
It was reported that stent fracture occurred.The target lesion was located in the right coronary artery.A 3.50x38mm synergy ii drug-eluting stent (des) was deployed for treatment.However, during an intravascular ultrasound, a fracture was noted.The lesion was ballooned and a 35x12mm synergy ii des was successfully deployed.There were no patient complications nor injuries 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: 9633327
• Report Number: 2134265-2020-00463
• Device Sequence Number: 11462968
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: 08714729840428
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 02/28/2020

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: 06/17/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024060256
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/28/2020
• 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