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

Model Number	H7493941820400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgment occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery (rca).After the lesion was prepped with semi-compliant balloons, the 4.00 x 20mm synergy xd mr stent delivery system (sds) was advanced on the guidewire through the guide catheter and non-boston scientific guide extension catheter.Once the sds was at the appropriate location, it was noticed that the stent was no longer on the balloon.X-ray was then used to trace back and locate the stent, which was found inside the guide catheter just distal to the sheath.All devices were removed from the patient and the stent was removed from the guide catheter by forcing it out with a wire.There was no harm to the patient and the procedure was completed successfully using a 4.0 x 38mm synergy xd.
Event or Problem Description
It was reported that stent dislodgment occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery (rca).After the lesion was prepped with semi-compliant balloons, the 4.00 x 20mm synergy xd mr stent delivery system (sds) was advanced on the guidewire through the guide catheter and non-boston scientific guide extension catheter.Once the sds was at the appropriate location, it was noticed that the stent was no longer on the balloon.X-ray was then used to trace back and locate the stent, which was found inside the guide catheter just distal to the sheath.All devices were removed from the patient and the stent was removed from the guide catheter by forcing it out with a wire.There was no harm to the patient and the procedure was completed successfully using a 4.0 x 38mm synergy xd.
Additional Manufacturer Narrative
The synergy xd mr us 4.00 x 20 mm stent delivery system was returned for analysis with the stent detached from the balloon.The stent outer diameter at the time of manufacturing within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.Crimp markings were evident on the exposed balloon.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14438656
• Report Number: 2134265-2022-05683
• Device Sequence Number: 5646157
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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
• Report Date (Section B): 07/21/2022

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: 01/09/2023
• Device Model Number: H7493941820400
• Device Lot Number: 0026623018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2021
• 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: Female