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

Model Number	H7493941816220
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Used (b)(6) 2022 (first day of the bsc aware date month) as the event date was not provided.
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with coronary artery disease (cad).The target lesion was located in the left anterior descending artery (lad).A 2.25 x 16mm synergy xd drug-eluting stent was advanced for treatment and was inflated at 8 atmospheres.However, when they came down with the balloon and pulled back the shaft, the stent detached from the balloon post inflation.The stent moved up the lad and was left in the middle left anterior descending artery.The procedure was completed successfully.There were no patient complications reported.
Additional Manufacturer Narrative
Used 01-apr-2022 (first day of the bsc aware date month) as the event date was not provided.
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with coronary artery disease (cad).The target lesion was located in the left anterior descending artery (lad).A 2.25 x 16mm synergy xd drug-eluting stent was advanced for treatment and was inflated at 8 atmospheres.However, when they came down with the balloon and pulled back the shaft, the stent detached from the balloon post inflation.The stent move up the lad and was left in the middle left anterior descending artery.There were no patient complications reported.It was further reported that the stent was deployed under nominal pressure and was not well apposed before it moved.The stent was post dilated at nominal pressure after it migrated.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14417150
• Report Number: 2134265-2022-05041
• Device Sequence Number: 20206184
• Product Code: NIQ
• UDI-Device Identifier: 08714729980728
• UDI-Public: 08714729980728
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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: 07/23/2023
• Device Model Number: H7493941816220
• Device Lot Number: 0027806774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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
• Patient Sex: Unknown