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

Device Problems Break (1069); Leak/Splash (1354); Difficult to Advance (2920)

Patient Problems Arrhythmia (1721); Bradycardia (1751)

Event Date 06/23/2022

Event Type  Injury  

Event Description

It was reported that shaft break occurred and the patient experienced bradycardia and arrhythmia.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 4.00 x 28mm synergy xd drug-eluting stent was selected for use.Upon loading on the wire, the wire exited the stent delivery before the monorail port.The wire was redirected and stent delivery was attempted.Upon inflation at about 1 to 2 atmospheres, a blood was noted in the stent delivery system and the balloon was leaking contrast.The delivery system was also noted to be broken at the proximal stent edge between the balloon and the monorail port.The device was not deployed and successfully retracted back into the guidezilla and everything was removed intact.The patient had arrhythmia and a neosynephrine was given for bradycardia.The procedure was completed with another of the same device.The patient was fully recovered.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15048296
• MDR Text Key: 296125442
• Report Number: 2134265-2022-07604
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 07/18/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female