MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT

Model Number	H7493941824300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Vascular Dissection (3160)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vascular dissection and vessel perforation occurred.The target lesion was located in a calcified and narrowed left anterior descending (lad) artery.After rotablation, a 3.00 x 24mm synergy xd drug-eluting stent and a 6f guidezilla ii guide extension catheter was advanced into the proximal lad.However, while preparing to inflate the stent, the patient suddenly moved and dissection and perforation in the proximal lad occurred.The physician asked for a covered stent and deliver it into the lad without success.Eventually, the patient was stable and an echocardiogram confirmed that there was a little perforation.Subsequent echocardiogram showed nothing.The physician then worked to stent the vessel with a synergy stent and was successful.It was not certain what caused the dissection and perforation.The circumflex was also stented and the procedure was completed.The patient was sent home over the weekend with no further complications and fully recovered.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15218079
• Report Number: 2134265-2022-08275
• Device Sequence Number: 20505269
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: 08714729980988
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2024
• Device Model Number: H7493941824300
• Device Lot Number: 0028959219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: White