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

Model Number	H7493941820250
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Codes	Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that stent damage occurred.Following pre-dilatation with a 2.5 x 20 balloon, a 2.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.Intravascular lithotripsy (ivl) was used to advance the stent but it failed to cross the lesion.The device was removed undeployed and it was noted that a stent strut was sticking out.No patient complications were reported.
Additional Manufacturer Narrative
Updated : b1: adverse event/product problem.B2: outcomes attrib to adv event.B5: describe event or problem.E1: initial reporter name.H1: type of reportable event.H6: patient code, impact code.
Event or Problem Description
It was reported that stent damage occurred.A 2.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent could not cross the lesion and found that the strut sticking out of stent.The procedure was completed with and there were no patient complications nor injuries reported.It was further reported that vascular access was obtained via femoral artery and the target lesion was mildly tortuous and severely calcified with 95% stenosis.The patient ended up with a frayed non-bsc guidewire and a distal vessel perforation.It was noted that when the stent and guidewire were removed together, a piece of wire was broken off in the second undeployed stent.The procedure was aborted due to wire perforation and the patient received protamine.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14214998
• Report Number: 2134265-2022-04836
• Device Sequence Number: 4124404
• Product Code: NIQ
• UDI-Device Identifier: 08714729980810
• UDI-Public: 08714729980810
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: 12/06/2023
• Device Model Number: H7493941820250
• Device Lot Number: 0028559184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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: Other
• Patient Sex: Unknown