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

Model Number	H7493941838350
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties and shaft break occurred requiring additional intervention.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The target lesions was located in the mildly tortuous and moderately calcified left anterior descending artery (lad).A 3.00 x 38mm stent was deployed in diagonal branch and the stent delivery system (sds) was removed, and a 3.50 x 38mm synergy xd drug-eluting stent (des) was also advanced for treatment as part of a kissing technique.However, the 3.50 x 38mm synergy xd des was repositioned slightly prior to inflation but it became stuck in the vessel.The des was retrieved easily; however, due to the interaction with the 3.00 x 38mm stent, it became stuck in the runway guide catheter.When pulled back, the stent shaft broke and detached.The distal portion of the sds along with the stent remained in place.A small balloon was then used to inflate and trap the sds in the guide catheter.The guide catheter along with the broken distal portion was removed, without further issue.Upon examination, the des broke proximal to the monorail port.The stent also appeared deformed and partially unraveled, due to being stuck with the 3.00 x 38mm stent.The procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
B5: additional information added.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred requiring additional intervention.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The target lesions was located in the mildly tortuous and moderately calcified left anterior descending artery (lad).A 3.00 x 38mm stent was deployed in diagonal branch and the stent delivery system (sds) was removed, and a 3.50 x 38mm synergy xd drug-eluting stent (des) was also advanced for treatment as part of a kissing technique.However, the 3.50 x 38mm synergy xd des was repositioned slightly prior to inflation but it became stuck in the vessel.The des was retrieved easily; however, due to the interaction with the 3.00 x 38mm stent, it became stuck in the runway guide catheter.When pulled back, the stent shaft broke and detached.The distal portion of the sds along with the stent remained in place.A small balloon was then used to inflate and trap the sds in the guide catheter.The guide catheter along with the broken distal portion was removed, without further issue.Upon examination, the des broke proximal to the monorail port.The stent also appeared deformed and partially unraveled, due to being stuck with the 3.00 x 38mm stent.The procedure was completed with another of the same device.There were no patient complications.It was further reported that the 3.00 x 38mm stent was a synergy xd des and was deployed with no issues.Additionally, the 3.50 x 38mm synergy xd des was repositioned prior to inflation to ensure geographic landing was accurate; and there were no attempts made to deploy the stent.Also.There was no damage observed with the guide catheter or the 3.00 x 38mm synergy xd des.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.50 x 38mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion identified that the polymer extrusion was stretched and there was a break in the midshaft approximately 3.8cm from the port exchange.The remainder of the detached device including the entire hypotube and manifold were not returned.Microscopic examination of the stent identified struts stretched in the mid-section.Microscopic examination identified that the inner lumen was stretched 7.8cm from the distal tip.Balloon cones were reviewed under microscopic examination, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Microscopic examination of the bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred requiring additional intervention.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The target lesions was located in the mildly tortuous and moderately calcified left anterior descending artery (lad).A 3.00 x 38mm stent was deployed in diagonal branch and the stent delivery system (sds) was removed, and a 3.50 x 38mm synergy xd drug-eluting stent (des) was also advanced for treatment as part of a kissing technique.However, the 3.50 x 38mm synergy xd des was repositioned slightly prior to inflation but it became stuck in the vessel.The des was retrieved easily; however, due to the interaction with the 3.00 x 38mm stent, it became stuck in the runway guide catheter.When pulled back, the stent shaft broke and detached.The distal portion of the sds along with the stent remained in place.A small balloon was then used to inflate and trap the sds in the guide catheter.The guide catheter along with the broken distal portion was removed, without further issue.Upon examination, the des broke proximal to the monorail port.The stent also appeared deformed and partially unraveled, due to being stuck with the 3.00 x 38mm stent.The procedure was completed with another of the same device.There were no patient complications.It was further reported that the 3.00 x 38mm stent was a synergy xd des and was deployed with no issues.Additionally, the 3.50 x 38mm synergy xd des was repositioned prior to inflation to ensure geographic landing was accurate; and there were no attempts made to deploy the stent.Also.There was no damage observed with the guide catheter or the 3.00 x 38mm synergy xd des.

• 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: 23310867
• Report Number: 2124215-2025-72522
• Device Sequence Number: 14900223
• Product Code: NIQ
• UDI-Device Identifier: 08714729981091
• UDI-Public: (01)08714729981091(17)270113(10)35793183
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 02/12/2026

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: H7493941838350
• Device Catalogue Number: H7493941838350
• Device Lot Number: 0035793183
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 01/21/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/12/2025; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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