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

Lot Number	0030807927
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/07/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a stent fracture occurred.A synergy xd mr us 4.00 x 32mm was selected for use during a percutaneous coronary intervention.During normal advancement, it was noted that the stent delivery system had broken into two pieces.The proximal portion of the device was able to be removed as it was still on the wire.Attempts were made to snare the distal portion that still remained in the patient, however these snaring attempts were unsuccessful.After this, the patient was taken to the cardiovascular operating room for emergency removal of the fractured device via open heart surgery.Due to this, the patient had died.
Event or Problem Description
It was reported that a stent fracture occurred.A synergy xd mr us 4.00 x 32mm was selected for use during a percutaneous coronary intervention.During normal advancement, it was noted that the stent delivery system had broken into two pieces.The proximal portion of the device was able to be removed as it was still on the wire.Attempts were made to snare the distal portion that still remained in the patient; however, these snaring attempts were unsuccessful.After this, the patient was taken to the cardiovascular operating room for emergency removal of the fractured device via open heart surgery.Due to this, the patient had died.It was further reported that it was the distal portion of the stent delivery system that had separated, and during surgery the delivery system was completely removed from the patient.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17839393
• Report Number: 2124215-2023-53080
• Device Sequence Number: 7666816
• Product Code: NIQ
• UDI-Device Identifier: 08714729981169
• UDI-Public: 08714729981169
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: 01/02/2025
• Device Lot Number: 0030807927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 10/08/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown