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

Model Number H7493941832220

Device Problems Leak/Splash (1354); Difficult to Remove (1528); Material Deformation (2976); Activation Failure (3270)

Patient Problems Myocardial Infarction (1969); Perforation of Vessels (2135); Thrombosis/Thrombus (4440)

Event Date 12/09/2021

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 283394058
• Report Number: 2134265-2021-16315
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980766
• UDI-Public: 08714729980766
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Race: White