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

Model Number	H7493941812250
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred resulting in additional intervention.The patient was presented with coronary artery disease and underwent percutaneous coronary intervention.The 70% stenosed target lesion was located in non-tortuous and moderately calcified coronary artery.A 2.50 x 12mm synergy xd drug eluting stent was attempted to advance in diagonal branch.However, the stent was stripped off from the stent delivery system.Attempts were made to slip a new balloon into the stent and dilate it but failed.Finally, the physician decided to crush the stent into the vessel wall by ballooning and deployed additional stent and the procedure completed.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
D6a implant date: corrected the synergy xd mr ous 2.50 x 12mm stent delivery system was returned for analysis.The device was returned without the stent.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture was within max crimped stent profile measurement.The balloon cones were reviewed, and signs of positive pressure applied to them were noted as the balloon folds were noted to be relaxed and crimp stent markings were visible on the balloon body.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found inner/outer kink located approximately 2.5cm from the exchange port.
Event or Problem Description
It was reported that stent dislodgement occurred resulting in additional intervention.The patient was presented with coronary artery disease and underwent percutaneous coronary intervention.The 70% stenosed target lesion was located in non-tortuous and moderately calcified coronary artery.A 2.50 x 12mm synergy xd drug eluting stent was attempted to advance in diagonal branch.However, the stent was stripped off from the stent delivery system.Attempts were made to slip a new balloon into the stent and dilate it but failed.Finally, the physician decided to crush the stent into the vessel wall by ballooning and deployed additional stent and the procedure completed.There were no patient complications nor injuries 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16598881
• Report Number: 2124215-2023-12432
• Device Sequence Number: 1700084
• Product Code: NIQ
• UDI-Device Identifier: 08714729980797
• UDI-Public: 08714729980797
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 04/24/2023

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: 11/09/2023
• Device Model Number: H7493941812250
• Device Lot Number: 0028452325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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 Age: 72 YR
• Patient Sex: Male