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

Model Number	H7493941832350
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.A percutaneous coronary intervention was being performed.Vascular access was obtained via the right femoral artery.The target lesion was located in the non-tortuous and non-calcified circumflex artery and obtuse marginal artery.Predilation was performed with a 2.5x12mm emerge balloon catheter.A 3.50 x 32mm synergy xd drug-eluting stent was advanced and deployed in the proximal circumflex artery for 14 seconds at 11 atm.However, during procedure, the stent dislodged and migrated to the aorta.The stent was removed via snare.An emerge 1.5x12mm balloon catheter was inflated for 29 seconds at 14 atm in the first obtuse marginal.Subsequently, a 2.50x28mm a synergy xd drug-eluting stent was advanced for treatment.However, during procedure, the stent was dislodged.The stent was removed via snare.The procedure was completed with a different device.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; two scimed place; maple grove MN 55311
• MDR Report Key: 12577011
• Report Number: 2134265-2021-12457
• Device Sequence Number: 3322278
• Product Code: NIQ
• UDI-Device Identifier: 08714729981084
• UDI-Public: 08714729981084
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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: 02/02/2023
• Device Model Number: H7493941832350
• Device Lot Number: 0026830248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Weight: 66