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

Model Number	H7493941838250
Medical Device Problem Codes	Fracture (1260); Nonstandard Device (1420); Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that device issues occurred requiring additional intervention.A 2.50 x 48 mm synergy drug eluting stent (des) was placed semi-emergently in the proximal to distal right coronary artery (rca) but did not quite reach the bifurcation of the posterior descending artery (pda) and the posterior lateral branch (plb).The stent was post-dilated with 3.00 and 3.50 non-complaint balloons consecutively.An attempt was then made to place a 2.50 x 38 mm synergy des distal and into the pda.However, the stent seemed to get stuck when it reached the proximal edge of the 48 mm synergy des.While trying to remove the 38 mm stent, it seemed to get hung up right outside the guide catheter in the ostial/proximal rca.Extreme force did not move the stent.A non-boston scientific guide extension catheter, a snare, and finally a trapping balloon, were used to remove everything (stent, wires, balloon) together.The stent was shredded and the wire was possibly sheared off by the 38 mm stent.The patient was taken to the operating room to remove the portion of the 38 mm stent that was still in the body.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Investigation results: device analysis findings: the 2.50 x 38mm synergy xd mr drug-eluting stent was returned for analysis.A visual and tactile examination within the hypotube found a break of 152.3cm from the distal tip with the hub/manifold which was not returned and the hypotube was concealed within a 6f guide catheter and could not be removed.A visual and tactile examination of the stent struts were damaged at the mid-section and were pulled over distal balloon cone and along the loaded 0.014 guidewire was another stent that was completely damaged.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.The balloon cones were not subjected to positive pressure and no signs of tip damage.A microscopic examination of the inner shaft polymer extrusion was stretched along the 0.014 loaded guidewire, 8.3cm from tip and the distal and proximal markerbands identified no damage.No other device issues were identified during returned product analysis.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this product investigation is assigned the most probable cause classification of adverse event related to procedure.This code was selected as the most probable complaint cause based on the information available.Analysis of the returned device confirmed the reported allegation.Stent struts were damaged from mid-section and pulled over the distal balloon cone and over the loaded guidewire.A second damaged stent was positioned more distally along the loaded guidewire.Interactions with the already placed stent and the 2.50x38mm synergy stent caused the advancement and removal difficulty.Stent struts within the proximal region were tightly crimped onto the balloon profile and the balloon was not subjected to positive pressure.
Event or Problem Description
It was reported that device issues occurred requiring additional intervention.A 2.50 x 48 mm synergy drug eluting stent (des) was placed semi-emergently in the proximal to distal right coronary artery (rca) but did not quite reach the bifurcation of the posterior descending artery (pda) and the posterior lateral branch (plb).The stent was post-dilated with 3.00 and 3.50 non-complaint balloons consecutively.An attempt was then made to place a 2.50 x 38 mm synergy des distal and into the pda.However, the stent seemed to get stuck when it reached the proximal edge of the 48 mm synergy des.While trying to remove the 38 mm stent, it seemed to get hung up right outside the guide catheter in the ostial/proximal rca.Extreme force did not move the stent.A non-boston scientific guide extension catheter, a snare, and finally a trapping balloon, were used to remove everything (stent, wires, balloon) together.The stent was shredded and the wire was possibly sheared off by the 38 mm stent.The patient was taken to the operating room to remove the portion of the 38 mm stent that was still in the body.

• 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: 24150872
• Report Number: 2124215-2026-04132
• Device Sequence Number: 13095308
• Product Code: NIQ
• UDI-Device Identifier: 08714729980858
• UDI-Public: (01)08714729980858(17)270526(10)36635936
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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
• Report Date (Section B): 04/20/2026

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: H7493941838250
• Device Catalogue Number: H7493941838250
• Device Lot Number: 0036635936
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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