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

Lot Number	0030864420
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The target lesion was located in the right coronary artery.After the vessel was prepped properly, a 2.75 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, due to calcific disease and tortuosity of the vessel, the stent could not be advanced to the target lesion.The undeployed stent was removed, and it was then noted that the stent was no longer in the balloon.Angiography was performed and it was confirmed that the stent was left in the coronary unintentionally.The physician wired the loose stent and inflated a balloon to secure it, and then removed it all as one unit.A new stent of the same size was used to complete the procedure successfully.No patient complications were reported, and the patient was fine post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.75 x 12mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.Visual examination identified the stent was not returned.The device was returned with no stent attached.The stent outer diameter at the time of manufacturing was within maximum crimped stent profile measurement.A visual and tactile examination identified no issues with the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic examination of balloon cones was reviewed, and no issues were noted.Crimp markings were visible on the balloon.Bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The target lesion was located in the right coronary artery.After the vessel was prepped properly, a 2.75 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, due to calcific disease and tortuosity of the vessel, the stent could not be advanced to the target lesion.The undeployed stent was removed, and it was then noted that the stent was no longer on the balloon.Angiography was performed and it was confirmed that the stent was left in the coronary unintentionally.The physician wired the loose stent and inflated a balloon to secure it, and then removed it all as one unit.A new stent of the same size was used to complete the procedure successfully.No patient complications were reported, and the patient was fine post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.75 x 12mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.Visual examination identified the stent was not returned.The device was returned with no stent attached.The stent outer diameter at the time of manufacturing was within maximum crimped stent profile measurement.A visual and tactile examination identified no issues with the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic examination of balloon cones was reviewed, and no issues were noted.Crimp markings were visible on the balloon.Bumper tip showed no signs of distal tip damage.Updated the following.A2: age at time of event and unit of measure - age, a3a: sex, and a3b: gender.
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The target lesion was located in the right coronary artery.After the vessel was prepped properly, a 2.75 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, due to calcific disease and tortuosity of the vessel, the stent could not be advanced to the target lesion.The undeployed stent was removed, and it was then noted that the stent was no longer on the balloon.Angiography was performed and it was confirmed that the stent was left in the coronary unintentionally.The physician wired the loose stent and inflated a balloon to secure it, and then removed it all as one unit.A new stent of the same size was used to complete the procedure successfully.No patient complications were reported, and the patient was fine post-procedure.The initial reporter also submitted a copy of this event or report to food and drug administration (fda).

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20004083
• Report Number: 2124215-2024-47854
• Device Sequence Number: 4915288
• Product Code: NIQ
• UDI-Device Identifier: 08714729980872
• UDI-Public: 08714729980872
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 12/10/2024

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: 01/04/2025
• Device Lot Number: 0030864420
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 11/18/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 10/07/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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: 82 YR
• Patient Sex: Male