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

Lot Number	0030335071
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 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 a device pinhole occurred.The target lesion was located in a coronary artery.A 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent failed to deploy.When the stent was removed, the delivery shaft appeared to have a pinhole in the distal third of the catheter.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that a device pinhole occurred.The target lesion was located in a coronary artery.A 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent failed to deploy.When the stent was removed, the delivery shaft appeared to have a pinhole in the distal third of the catheter.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the target lesion was 80% stenosed and mildly tortuous with mild angulation.It is unknown if the pinhole was present upon removal from the packaging.The pinhole was discovered after the stent was removed because it would not deploy during inflation.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: synergy xd mr us 2.25 x 20mm stent delivery system (sds) was returned for analysis.Visual, tactile, microscopic and functional analysis was performed on the device.No issues were identified with the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found a 3mm cut distal from the port exchange on the outer lumen.There was no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed and were subjected to positive pressure.The bumper tip showed no signs of distal tip damage.An attempt was then made to inflate the balloon, using an inflation aid attached, however, pressure was unable to be maintained as inflation liquid was observed leaking from the port exchange.No other device issues were identified during returned product analysis.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17393581
• Report Number: 2124215-2023-35058
• Device Sequence Number: 15688936
• Product Code: NIQ
• UDI-Device Identifier: 08714729980735
• UDI-Public: 08714729980735
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• 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): 08/18/2023

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: 10/02/2024
• Device Lot Number: 0030335071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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
• Patient Sex: Unknown