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

Model Number	10607
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous proximal left anterior descending artery (lad).A 4.00 x 38mm synergy drug-eluting stent was implanted in the proximal lad.However, when the physician removed the stent balloon, it got stuck in the strut and separated from the delivery system.The physician used a different balloon to trap the stent balloon in the guide catheter and removed everything while leaving deployed stent intact.The procedure was completed with no patient complications were reported.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous proximal left anterior descending artery (lad).A 4.00 x 38mm synergy drug-eluting stent was implanted in the proximal lad.However, when the physician removed the stent balloon, it got stuck in the strut and separated from the delivery system.The physician used a different balloon to trap the stent balloon in the guide catheter and removed everything while leaving deployed stent intact.The procedure was completed with no patient complications were reported.It was further reported that the balloon was detached.
Additional Manufacturer Narrative
Updated b5: describe event or problem.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous proximal left anterior descending artery (lad).A 4.00 x 38mm synergy drug-eluting stent was implanted in the proximal lad.However, when the physician removed the stent balloon, it got stuck in the strut and separated from the delivery system.The physician used a different balloon to trap the stent balloon in the guide catheter and removed everything while leaving deployed stent intact.The procedure was completed with no patient complications were reported.It was further reported that the balloon was detached.It was further reported that the lesion was calcified with minimal bends.The ballloon was inflated/ deflated once after the initial stent deployment and the balloon was stuck in the stent strut/lad lesion.

• 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: 12268685
• Report Number: 2134265-2021-09840
• Device Sequence Number: 5061597
• Product Code: NIQ
• UDI-Device Identifier: 08714729840435
• UDI-Public: 08714729840435
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2021

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: 02/10/2023
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0026856578
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 08/03/2021; 08/11/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 08/11/2021; 08/18/2021
• 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 CATHETER: EBU 3.5 FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR