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

Model Number H7493941838300

Device Problem Material Rupture (1546)

Patient Problem Vascular Dissection (3160)

Event Date 03/01/2022

Event Type  Injury  

Event 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
• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14058331
• MDR Text Key: 288987991
• Report Number: 2134265-2022-04185
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: 08714729981015
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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): Required Intervention
• Patient Sex: Female