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

Model Number	H7493941832220
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Perforation of Vessels (2135); Thrombosis/Thrombus (4440)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that insufficient apposition, removal difficulty, vessel perforation, acute thrombosis, and myocardial infarction were encountered.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified distal circumflex artery.A 2.25 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, upon inflation, the stent balloon was only able to inflate to 3 atmospheres before losing pressure which resulted in a partially deployed stent.The physician tried to remove the balloon but it was stuck.He pulled back the balloon harder which freed the balloon but it caused the wire to jump forward resulting in a perforation of the artery.The device was removed intact and a hypotube kink was noted.Atrial fibrillation and subsequent thrombosis were encountered and the patient experienced st-segment elevation myocardial infarction.The patient's artery was coiled off to treat the perforation.No further complications were reported and the patient status post-procedure was stable.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13180339
• Report Number: 2134265-2021-16315
• Device Sequence Number: 14886567
• Product Code: NIQ
• UDI-Device Identifier: 08714729980766
• UDI-Public: 08714729980766
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 01/06/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2022
• Device Model Number: H7493941832220
• Device Lot Number: 0025663672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Race: White