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

Model Number	H7493941838250
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified second obtuse marginal artery.A 2.50 x 38mm synergy xd drug-eluting stent was advanced for treatment.Inflation was performed at 16 atmospheres for 15 seconds.However, during withdrawal, it was noticed that the balloon felt like it was sticking to the inside of the stent and was difficult to remove.The balloon was fully deflated and was able to be removed intact.The procedure was completed with the original device.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulties were encountered.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified second obtuse marginal artery.A 2.50 x 38mm synergy xd drug-eluting stent was advanced for treatment.Inflation was performed at 16 atmospheres for 15 seconds.However, during withdrawal, it was noticed that the balloon felt like it was sticking to the inside of the stent and was difficult to remove.The balloon was fully deflated and was able to be removed intact.The procedure was completed with the original device.No patient complications were reported.It was further reported that a 6f guide catheter was used and that 6 seconds were waited for balloon deflation before pulling back the device.Absence of contrast within the balloon was confirmed under fluoroscopy.

• 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: 11614687
• Report Number: 2134265-2021-03462
• Device Sequence Number: 16933906
• Product Code: NIQ
• UDI-Device Identifier: 08714729980858
• UDI-Public: 08714729980858
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 12/01/2022
• Device Model Number: H7493941838250
• Device Lot Number: 0026532758
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1