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

Lot Number	0030962832
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon did not fully deflate.The patient presented experiencing a st-elevation myocardial infarction.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 4.00 x 48 mm synergy xd stent was successfully deployed.The delivery system balloon was then inflated at 15 atm.After many attempts to pull negative pressure for several seconds, the balloon failed to fully deflate and could not be retracted through the guide catheter.The guide catheter, guidewire and partially inflated balloon were pulled and removed as a unit.The procedure was completed successfully with no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.Product analysis: synergy xd mr us 4.00 x 48mm stent delivery system (sds) was returned for analysis.Visual, tactile, microscopic, functional and device-to-device interaction analysis was performed on the device.The device was returned with a guidewire and an nc balloon, all inside the guide catheter.Analysis revealed a break occurring 116.5 cm proximal from the port exchange and multiple kinks along the hypotube shaft.No device issues were found that could have contributed to the break.The manifold was not returned.Severe stretching was found in the midshaft and at the guidewire exchange area of the shaft polymer extrusion profile.The stent was deployed successfully during the procedure and was not attached to the balloon.The balloon cones showed that positive pressure had been applied to the balloon.The balloon was in a deflated state.With the manifold detached the device was attached to an inflation aid.Multiple attempts were made to inflate/deflate the balloon however the inflation liquid could not reach the balloon.The failure to inflate is consistent with the severe stretching along the midshaft.With the two devices inside the guide catheter, resistance was felt when attempting to remove.After soaking in the water bath at 37 degrees, both devices could be removed.
Event or Problem Description
It was reported that the balloon did not fully deflate.The patient presented experiencing a st-elevation myocardial infarction.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 4.00 x 48 mm synergy xd stent was successfully deployed.The delivery system balloon was then inflated at 15 atm.After many attempts to pull negative pressure for several seconds, the balloon failed to fully deflate and could not be retracted through the guide catheter.The guide catheter, guidewire and partially inflated balloon were pulled and removed as a unit.The procedure was completed successfully with no patient complications reported.

• 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: 18445052
• Report Number: 2124215-2023-72253
• Device Sequence Number: 20523332
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: 08714729985242
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2025
• Device Lot Number: 0030962832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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
• Patient Sex: Unknown