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

Lot Number	0033754577
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Activation Failure (3270)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadequate apposition and removal difficulty occurred.The target lesion was located in the obtuse marginal.A 2.75 x 38mm synergy xd drug-eluting stent was advanced for treatment with a balloon.The stent did not fully expand in the middle and when the stent balloon was deflated and retracted into the guide catheter, it would not move.An attempt to deflate the stent balloon was made, however the device remained stuck.The device was pulled and the attempt unsheathed a large portion of the shaft to the device leaving both the stent balloon and the device shaft in the vessel hanging into the aorta.An attempt was made to re-wire the vessel and use other balloons or snaring devices to free the balloon and shaft, however was unsuccessful.To conclude, a stent was placed down the left main into the proximal left anterior descending (lad) artery and another stent down the circumflex to protect the main vessels.
Event or Problem Description
It was reported via (b)(4) that inadequate apposition and removal difficulty occurred.The target lesion was located in the obtuse marginal.A 2.75 x 38mm synergy xd drug-eluting stent was advanced for treatment with a balloon.The stent did not fully expand in the middle and when the stent balloon was deflated and retracted into the guide catheter, it would not move.An attempt to deflate the stent balloon was made, however the device remained stuck.The device was pulled and the attempt unsheathed a large portion of the shaft to the device leaving both the stent balloon and the device shaft in the vessel hanging into the aorta.An attempt was made to re-wire the vessel and use other balloons or snaring devices to free the balloon and shaft, however was unsuccessful.To conclude, a stent was placed down the left main into the proximal left anterior descending (lad) artery and another stent down the circumflex to protect the main vessels.It was further reported that not all parts was recovered.The tip of the catheter including the balloon portion was not recovered.The patient was stable and was discharge.

• 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: 20568108
• Report Number: 2124215-2024-65820
• Device Sequence Number: 7481050
• Product Code: NIQ
• UDI-Device Identifier: 08714729980933
• UDI-Public: 08714729980933
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2026
• Device Lot Number: 0033754577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/25/2024
• Date Device Manufactured: 03/20/2024
• 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
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White