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

Model Number	H7493941838300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch (b)(4) that a balloon rupture and dissection occurred.The patient was transported to the hospital with chest pain and st elevation myocardial infarction.The 100% stenosed target lesion with a significant bend of 45 degrees was located in the moderately tortuous and moderately calcified left anterior descending coronary artery.After one stent was implanted, the 3.00 x 38mm synergy xd was advanced to the target lesion.Upon initial inflation, the stent delivery system (sds) balloon would not inflate and when the balloon was deflated, there was evidence of blood in the indeflator consistent with a ruptured balloon.As the sds was being removed from the patient, a small dissection occurred which required a third stent to repair.There were no further patient complications reported.The patient condition was stable but they required continued observation in the hospital.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14058331
• Report Number: 2134265-2022-04185
• Device Sequence Number: 4986808
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: 08714729981015
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2022

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: 06/14/2023
• Device Model Number: H7493941838300
• Device Lot Number: 0027548932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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 Sex: Female