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

Model Number	H7493941848270
Medical Device Problem Codes	Positioning Failure (1158); Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon ruptured occurred.The 99% stenosed target lesion was located in the mildly calcified mid right coronary artery.The lesion was pre-dilated.A 2.75 x 48mm synergy xd drug-eluting stent was advanced without resistance over a non-boston scientific guidewire for treatment.Upon attempting to deploy the stent, it was noted that it was losing pressure at 7 atmospheres for 5 seconds and the stent failed to deploy.There was blood return in the inflation device.The device was completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that a balloon ruptured occurred.The 99% stenosed target lesion was located in the mildly calcified mid right coronary artery.The lesion was pre-dilated.A 2.75 x 48mm synergy xd drug-eluting stent was advanced without resistance over a non-boston scientific guidewire for treatment.Upon attempting to deploy the stent, it was noted that that it was losing pressure at 7 atmospheres for 5 seconds and the stent failed to deploy.There was blood return in the inflation device.The device was completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the balloon was failed to inflate and was not ruptured as what previously reported.
Additional Manufacturer Narrative
H6: device codes: corrected from material rupture to inflation problem.

• 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: 13480337
• Report Number: 2134265-2022-01124
• Device Sequence Number: 5437563
• Product Code: NIQ
• UDI-Device Identifier: 08714729985211
• UDI-Public: 08714729985211
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 02/25/2022

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: 11/19/2022
• Device Model Number: H7493941848270
• Device Lot Number: 0026436824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: XT WIRE; GUIDEWIRE: XT WIRE
• Patient Sex: Female
• Patient Race: White