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

Model Number	H7493941838270
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Failure to Advance (2524); Detachment of Device or Device Component (2907); Activation Failure (3270)
Health Effect - Clinical Codes	Urinary Retention (2119); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device issue occurred resulting in patient complications.The at least 70% stenosed target lesion was located in the mildly tortuous and moderately calcified mid-right coronary artery.A 2.75 x 38 mm synergy xd drug-eluting stent (des) was advanced but failed to cross the lesion.A non-boston scientific guide extension was then used to deliver the stent.However, during initial inflation, the stent delivery system (sds) balloon ruptured before reaching the nominal pressure of 11 atmospheres.When the sds was removed, it was noted that the hyptube was broken and the balloon, which was broke off the hypotube, had been left behind inside the partially expanded stent.The patient experienced urinary retention and the vessel was occluded.The balloon could not be snared, so a second stent was deployed, crushing the balloon inside the first stent.The patient was monitored because the distal part of the stent could not be fully expanded.The patient fully recovered.
Event or Problem Description
It was reported that a device issue occurred resulting in patient complications.The at least 70% stenosed target lesion was located in the mildly tortuous and moderately calcified mid-right coronary artery.A 2.75 x 38 mm synergy xd drug-eluting stent (des) was advanced but failed to cross the lesion.A non-boston scientific guide extension was then used to deliver the stent.However, during initial inflation, the stent delivery system (sds) balloon ruptured before reaching the nominal pressure of 11 atmospheres.When the sds was removed, it was noted that the hyptube was broken and the balloon, which was broke off the hypotube, had been left behind inside the partially expanded stent.The patient experienced urinary retention and the vessel was occluded.The balloon could not be snared, so a second stent was deployed, crushing the balloon inside the first stent.The patient was monitored because the distal part of the stent could not be fully expanded.The patient fully recovered.Previously it was reported that a urinary retention occurred.However, it is now reported that there was no issue.
Event or Problem Description
It was reported that a device issue occurred resulting in-patient complications.The at least 70% stenosed target lesion was located in the mildly tortuous and moderately calcified mid-right coronary artery.A 2.75 x 38 mm synergy xd drug-eluting stent (des) was advanced but failed to cross the lesion.A non-boston scientific guide extension was then used to deliver the stent.However, during initial inflation, the stent delivery system (sds) balloon ruptured before reaching the nominal pressure of 11 atmospheres.When the sds was removed, it was noted that the hyptube was broken and the balloon, which was broke off the hypotube, had been left behind inside the partially expanded stent.The patient experienced urinary retention and the vessel was occluded.The balloon could not be snared, so a second stent was deployed, crushing the balloon inside the first stent.The patient was monitored because the distal part of the stent could not be fully expanded.The patient fully recovered.It was further reported that previously a urinary retention occurred.However, it is now reported that there was no issue.It was further reported via medwatch mw5176349 that the tip was fractured leaving partial balloon and stent in the right coronary artery.
Event or Problem Description
It was reported that a device issue occurred resulting in patient complications.The at least 70% stenosed target lesion was located in the mildly tortuous and moderately calcified mid-right coronary artery.A 2.75 x 38 mm synergy xd drug-eluting stent (des) was advanced but failed to cross the lesion.A non-boston scientific guide extension was then used to deliver the stent.However, during initial inflation, the stent delivery system (sds) balloon ruptured before reaching the nominal pressure of 11 atmospheres.When the sds was removed, it was noted that the hyptube was broken and the balloon, which was broke off the hypotube, had been left behind inside the partially expanded stent.The patient experienced urinary retention and the vessel was occluded.The balloon could not be snared, so a second stent was deployed, crushing the balloon inside the first stent.The patient was monitored because the distal part of the stent could not be fully expanded.The patient fully recovered.It was further reported that previously a urinary retention occurred.However, it is now reported that there was no issue.It was further reported via medwatch mw5176349 that the tip was fractured leaving partial balloon and stent in the right coronary artery.
Additional Manufacturer Narrative
Device evaluated by mfr: a section of the synergy xd mr us 2.75 x 38mm was returned for analysis.A visual and tactile examination identified no kinks or damages along the entire length of the hypotube.A visual and tactile examination of the distal extrusion identified a break in the the midshaft (laser section) 107.9cm from distal strain relief.The distal section of the break, including the distal extrusion shaft, balloon and tip sections of the device, were not returned for analysis.A microscopic examination of the break site in the midshaft extrusion, identified a break in the laser cut region at same location 107.9cm from distal strain relief.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23197079
• Report Number: 2124215-2025-68317
• Device Sequence Number: 9989312
• Product Code: NIQ
• UDI-Device Identifier: 08714729980933
• UDI-Public: (01)08714729980933(17)261112(10)35360769
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/22/2025

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: 0035360769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 10/08/2025; 10/15/2025; 11/28/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 10/16/2025; 10/30/2025; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White