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

Model Number	H7493941812220
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with acute coronary syndrome and underwent percutaneous coronary intervention.The target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery (lad).A 2.25 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, when placing the device in the lad, the stent slipped off the balloon proximal to the lesion.Subsequently, the dislodged stent was inflated and deployed in place.Another stent was advanced to treat the lesion but failed to cross.The physician decided to advance a non-boston scientific stent and was deployed successfully.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with acute coronary syndrome and underwent percutaneous coronary intervention.The target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery (lad).A 2.25 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, when placing the device in the lad, the stent slipped off the balloon proximal to the lesion.Subsequently, the dislodged stent was inflated and deployed in place.Another stent was advanced to treat the lesion but failed to cross.The physician decided to advance a non-boston scientific stent and was deployed successfully.No patient complications were reported.It was further reported that the 2.25 x 12mm synergy xd drug-eluting stent was initially unable to cross the lesion.There was no pre-dilatation done in the circumflex or obtuse marginal (om).It appeared calcified ostial circumflex but still going to stent the obtuse marginal 1 (om1).The stent crossed the circumflex into om1 but could not cross initially with synergy stent over non-boston scientific wire.When pulling the stent back, it came off the balloon of the stent delivery system in proximal circumflex.The physician then used a small 1.5 emerge push balloon catheter to inflate the undeployed stent in the proximal lesion of the om1 and used a bigger balloon to then open the stent.
Additional Manufacturer Narrative
B5.Describe event or problem- updated.

• 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: 16246802
• Report Number: 2124215-2023-02044
• Device Sequence Number: 6605693
• Product Code: NIQ
• UDI-Device Identifier: 08714729980711
• UDI-Public: 08714729980711
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 02/21/2023

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: 08/24/2024
• Device Model Number: H7493941812220
• Device Lot Number: 0030066427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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