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

Model Number	H7493941838250
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation issue and balloon rupture occurred requiring additional intervention.The patient presented with angina and underwent percutaneous coronary intervention.The target lesion was located in the mildly tortuous and mildly calcified right coronary artery.A 2.50 x 38mm synergy xd drug-eluting stent was advanced for treatment.However, during deployment, the stent balloon reached 4 atmospheres and would not inflate any further.The physician saw contrast travel distal to the stent and the blood came back into the inflation device, signaling a possible balloon rupture.Balloon deflation failed despite multiple attempts.The physician then cut the hub of the stent catheter and inserted a guide extension catheter over it, however, that did not work.The physician deep seeded the guide and was able to get some movement, which ultimately resulted in device removal.The stent found its way to the skin track along the femoral artery and was cut out with a scalpel.The device was removed in pieces and in deflated state.The procedure was completed using an alternate device, and no patient complications were reported.
Event or Problem Description
It was reported that deflation issue and balloon rupture occurred requiring additional intervention.The patient presented with angina and underwent percutaneous coronary intervention.The target lesion was located in the mildly tortuous and mildly calcified right coronary artery.A 2.50 x 38mm synergy xd drug-eluting stent was advanced for treatment.However, during deployment, the stent balloon reached 4 atmospheres and would not inflate any further.The physician saw contrast travel distal to the stent and the blood came back into the inflation device, signaling a possible balloon rupture.Balloon deflation failed despite multiple attempts.The physician then cut the hub of the stent catheter and inserted a guide extension catheter over it, however, that did not work.The physician deep seeded the guide and was able to get some movement, which ultimately resulted in device removal.The stent found its way to the skin track along the femoral artery and was cut out with a scalpel.The device was removed in pieces and in deflated state.The procedure was completed using an alternate device, and no patient complications were reported.It was further reported that during the procedure, the shaft broke inside the patient.
Additional Manufacturer Narrative
H6.Device codes- added shaft break.Device evaluated by mfr.: synergy xd mr us 2.50 x 38mm was returned for analysis and the following attributes were examined: as the manifold section of the device was not returned with the device, it is not possible to determine the manifold number.A visual, microscopic examination confirmed a dissection in the hypotube.The dissection was located towards the proximal end of the hypotube as the returned section of hypotube measured 120cm from the laser cut section to the break site.A visual and microscopic examination of the distal extrusion confirmed that a break exited in the midshaft section of the device, approximately 6.5cm distal to the hypotube bond.The distal section of the break, including the distal sections of the extrusion, balloon and tip were not received for analysis.A severely damaged, detached stent was received tangled to surgical scissors.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16791903
• Report Number: 2124215-2023-16602
• Device Sequence Number: 12143138
• Product Code: NIQ
• UDI-Device Identifier: 08714729980858
• UDI-Public: 08714729980858
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 06/02/2023

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: 06/14/2024
• Device Model Number: H7493941838250
• Device Lot Number: 0029647581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female