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

Device Problem Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

It was reported that the device would not deflate.The 100% stenosed target lesion was located in the mildly tortuous and mildly calcified artery.A 4.5x32 synergy xd was selected for use.Upon removal, it was noted that the stent delivery balloon would not deflate enough that it would not retract through gzii guide extension catheter ultimately causing the physician to remove everything from the patient.No patient complications reported.

Event Description

It was reported that the device would not deflate.The 100% stenosed target lesion was located in the mildly tortuous and mildly calcified artery.A 4.5x32 synergy xd was selected for use.Upon removal, it was noted that the stent delivery balloon would not deflate enough that it would not retract through gzii guide extension catheter ultimately causing the physician to remove everything from the patient.No patient complications reported.It was further reported that the operator waited for several seconds for balloon deflation before pulling back the device.

• 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: 16048704
• MDR Text Key: 307680290
• Report Number: 2124215-2022-54279
• 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,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/26/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 01/30/2023
• 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