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

Model Number	H7493941824350
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The patient presented for multivessel percutaneous coronary intervention with a non-boston scientific (bsc) heart pump in use.The 80 to 90% stenosed target lesion was located in the severely calcified proximal circumflex artery.A rotapro and a non-bsc lithotripsy balloon were utilized with no patient issues.Seven stents were deployed with no patient complications.A 3.50 x 24 mm synergy xd drug-eluting stent (des) was deployed, and afterward, the physician instructed the technician to inflate the stent delivery system balloon to 30 atm before removing the system.The balloon was inflated for 20 seconds and then fully deflated after about 5 seconds.During removal, the hypotube or balloon got stuck.Resistance was encountered and the device was removed with force causing the hypotube to snap inside the patient.Balloon markerbands showed that a portion of the hypotube was sitting between the left main and aorta.Following consultation with a surgeon, the decision was made to attempt to retrieve the device fragment with a snare.Anesthesia was called to intubate the patient.Multiple unsuccessful attempts were made to snare the fragment before the decision was made to deploy a stent in the left main to tack the fragment to the left main wall and complete the procedure.The patient was admitted to the intensive care unit for observation.The next day the patient was brought back to the catheter lab to reapply the non-bsc heart pump, but the patient died.

• 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: 20894761
• Report Number: 2124215-2024-77803
• Device Sequence Number: 18336173
• Product Code: NIQ
• UDI-Device Identifier: 08714729981060
• UDI-Public: 08714729981060
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

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: 01/15/2026
• Device Model Number: H7493941824350
• Device Catalogue Number: H7493941824350
• Device Lot Number: 0033300695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/10/2024
• Date Device Manufactured: 01/16/2024
• 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
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Race: White