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

Model Number	10607
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that difficulty removal occurred.The target lesion was located in the right coronary artery.A 4.00 x 38 synergy drug-eluting stent was selected and placed.However, upon removal, the balloon would not re-wrap and would not go into the guide catheter.The physician used a new guide catheter and then removed all devices as a whole.The balloon was removed in a deflated state and completed the procedure.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device is a combination product.Bsc aware date corrected from 07/02/2020 to 07/03/2020.
Event or Problem Description
It was reported that difficulty removal occurred.The target lesion was located in the right coronary artery.A 4.00 x 38 synergy drug-eluting stent was selected and placed.However, upon removal, the balloon would not re-wrap and would not go into the guide catheter.The physician used a new guide catheter and then removed all devices as a whole.The balloon was removed in a deflated state and completed the procedure.No patient complications were reported and the patient's status was stable.It was further reported that the clacified lesion was pre-treated with coronary orbital atherectomy system and a non-compliant balloon before stenting.The balloon was inflated once at 20 atmospheres for 9 seconds after initial stent deployment.

• 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: 10305942
• Report Number: 2134265-2020-09087
• Device Sequence Number: 3217737
• Product Code: NIQ
• UDI-Device Identifier: 08714729840435
• UDI-Public: 08714729840435
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 08/27/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024361060
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR