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

Model Number	H7493941832350
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Nonstandard Device (1420); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The target lesion was located in a mildly tortuous and calcified mid left anterior descending artery (lad).A 6fr a non-boston scientific (non-bsc) introducer sheath was inserted.After a non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 3.5x20 mm nc emerge balloon catheter at 14 atmospheres.A 3.50 x 32mm synergy xd was advanced and crossed the lesion without difficulty.Upon inflation at 2 atmospheres, a lack of resistance was noted in the encore endeflator.The technician made repeated attempts were made to inflate the stent balloon, but the same result was observed.Angiographic imaging confirmed that the stent balloon was not inflating.The physician also attempted inflation but encountered the same issue, and it was concluded that the balloon prematurely burst.During withdrawal, the delivery system became separated from the stent and the stent and balloon remained lodged within the lad, partially encapsulated by the guide catheter.The guide catheter was deeply seated in an attempt to recapture the stent and delivery system.A balloon was placed next to the stent and delivery balloon and the device fragment was snared.Everything was removed and the procedure was competed with an alternate device.There were no patient complications.
Additional Manufacturer Narrative
B5 describe event or problem and h6 device codes: corrected.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a mildly tortuous and calcified mid left anterior descending artery (lad).A 6fr a non-boston scientific (non-bsc) introducer sheath was inserted.After a non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 3.5x20 mm nc emerge balloon catheter at 14 atmospheres.A 3.50 x 32mm synergy xd was advanced and crossed the lesion without difficulty.Upon inflation at 2 atmospheres, a lack of resistance was noted in the encore endeflator.The technician made repeated attempts were made to inflate the stent balloon, but the same result was observed.Angiographic imaging confirmed that the stent balloon was not inflating.The physician also attempted inflation but encountered the same issue, and it was concluded that the balloon prematurely burst.During withdrawal, the delivery system became separated from the stent and the stent and balloon remained lodged within the lad, partially encapsulated by the guide catheter.The guide catheter was deeply seated in an attempt to recapture the stent and delivery system.A balloon was placed next to the stent and delivery balloon and the device fragment was snared.Everything was removed and the procedure was competed with an alternate device.There were no patient complications.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a mildly tortuous and calcified mid left anterior descending artery (lad).A 6fr a non-boston scientific (non-bsc) introducer sheath was inserted.After a non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 3.5x20 mm nc emerge balloon catheter at 14 atmospheres.A 3.50 x 32mm synergy xd was advanced and crossed the lesion without difficulty.Upon inflation at 2 atmospheres, a lack of resistance was noted in the encore endeflator.The technician made repeated attempts were made to inflate the stent balloon, but the same result was observed.Angiographic imaging confirmed that the stent balloon was not inflating.The physician also attempted inflation but encountered the same issue, and it was concluded that the balloon prematurely burst.During withdrawal, the delivery system became separated from the stent and the stent and balloon remained lodged within the lad, partially encapsulated by the guide catheter.The guide catheter was deeply seated in an attempt to recapture the stent and delivery system.A balloon was placed next to the stent and delivery balloon and the device fragment was snared.Everything was removed and the procedure was competed with an alternate device.There were no patient complications.
Additional Manufacturer Narrative
An angiographic image provided by the customer was reviewed and found to show a guidewire through lad as well as a guidecatheter at the ostium of lm.No markerbands of a balloon delivery system or stent are noted to be present in the vessel or within the guidecatheter.The media cannot confirm the reported allegation.
Additional Manufacturer Narrative
An angiographic image provided by the customer was reviewed and found to show a guidewire through lad as well as a guidecatheter at the ostium of lm.No markerbands of a balloon delivery system or stent are noted to be present in the vessel or within the guidecatheter.The media cannot confirm the reported allegation.The returned device consisted of the synergy xd stent delivery system.A visual inspection showed multiple kinks along the hypotube shaft.The shaft polymer extrusion and midshaft were stretched throughout.There was a break in the midshaft identified underneath where a lasercut break was, 106.8cm distal to the distal end of the strain relief.A microscopic analysis showed stent struts pulled distally and bunched towards the mid to distal section of the balloon.Crimp marks were visible on the balloon cones.The device was left in the water bath at 37 degrees celsius.An inflation attempt was made on the proximal section of the broken device.The device was attached to a hemostatic valve which in turn was attached to the manifold section of the synergy xd device.Positive pressure was applied to the system however pressure could not be sustained in the inflation device due to a leak coming from within the break noted previously in the lasercut section.No liquid was noted leaking through the distal end of the hypotube/lasercut section.He device was returned broken in the lasercut/midshaft region.Inflation liquid was seen coming from this section of the device.The distal section of the device had multiple locations of stretching in the midshaft, shaft polymer extrusion and inner lumen of the device.The stent was bunched and pulled distally towards the mid to distal section of the stent.Attempts to inflate the distal section led to the proximal and distal sections of the balloon inflating however a constraint was noted where the stent struts were bunched in the mid-section of the balloon.Multiple kinks were identified along the hypotube shaft.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a mildly tortuous and calcified mid left anterior descending artery (lad).A 6fr a non-boston scientific (non-bsc) introducer sheath was inserted.After a non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 3.5x20 mm nc emerge balloon catheter at 14 atmospheres.A 3.50 x 32mm synergy xd was advanced and crossed the lesion without difficulty.Upon inflation at 2 atmospheres, a lack of resistance was noted in the encore endeflator.The technician made repeated attempts were made to inflate the stent balloon, but the same result was observed.Angiographic imaging confirmed that the stent balloon was not inflating.The physician also attempted inflation but encountered the same issue, and it was concluded that the balloon prematurely burst.During withdrawal, the delivery system became separated from the stent and the stent and balloon remained lodged within the lad, partially encapsulated by the guide catheter.The guide catheter was deeply seated in an attempt to recapture the stent and delivery system.A balloon was placed next to the stent and delivery balloon and the device fragment was snared.Everything was removed and the procedure was competed with an alternate device.There were no patient complications.An angiographic image provided by the customer was reviewed and found to show a guidewire through lad as well as a guidecatheter at the ostium of lm.No markerbands of a balloon delivery system or stent are noted to be present in the vessel or within the guidecatheter.The media cannot confirm the reported allegation.

• 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: 22393616
• Report Number: 2124215-2025-43936
• Device Sequence Number: 9401257
• Product Code: NIQ
• UDI-Device Identifier: 08714729981084
• UDI-Public: (01)08714729981084(17)251129(10)33025531
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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,Followup,Followup
• Report Date (Section B): 01/16/2026

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 Expiration Date: 11/29/2025
• Device Model Number: H7493941832350
• Device Catalogue Number: H7493941832350
• Device Lot Number: 0033025531
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 10/13/2025; 12/23/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/12/2025; 10/23/2025; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Race: White