MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY? XD; coronary drug-eluting stent

Model Number	H7493941838270
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Codes	Chest Pain (1776); Non specific EKG/ECG Changes (1817)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation failure occurred resulting in patient complications and additional intervention.The left anterior descending (lad) coronary artery was noted to provide two diagonal branches and terminated as the apical recurrent branch.The proximal lad was noted to have diffuse long 50 to 60% disease with 80 to 90% mid disease.Following atherectomy of the lad, direct stenting was performed with a 2.75 x 38 mm synergy xd drug eluting stent.The stent delivery system (sds) balloon was inflated for 10-15 seconds during stent implantation and post implant, was deflated for 20 seconds before attempting to pull back the device.The proximal segment remained inflated, however, and only the distal portion of the balloon was deflated.The sds was stuck in the patient for approximately 20 minutes and during that time, the patient reported chest pain and st elevations were noted.Multiple attempts were made to puncture the inflated balloon with different wires and micro catheters, but all failed.A 3-way stop cock was then connected and the technician continued to draw negative until the balloon deflated and was removed.The open-heart team had been called to perform further intervention to remove the sds, but the balloon was able to be deflated at the last moment before the patient was to be taken to the operating room.The balloon was inflated outside the patient to see if it was punctured or ruptured but it was able to maintain pressure.The patient condition post-procedure was stable and the patient was discharged.

• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50893097
• Report Number: 2124215-2026-51095
• Device Sequence Number: 10706051
• Product Code: NIQ
• UDI-Device Identifier: 08714729980933
• UDI-Public: (01)08714729980933(17)280330(10)39099573
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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 Model Number: H7493941838270
• Device Catalogue Number: H7493941838270
• Device Lot Number: 0039099573
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 03/31/2026
• 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: Required Intervention
• Patient Sex: Unknown