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

Model Number	H7493941832350
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 32mm synergy xd drug-eluting stent was selected for use.However, when the physician inserted the stent on the guidewire, it was noticed that the stent was not exiting the guide catheter and was getting close to the hub.Upon checking in the guide catheter, the device was fractured.The guide catheter, guidewire and stent was removed all together.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 32mm synergy xd drug-eluting stent was selected for use.However, when the physician inserted the stent on the guidewire, it was noticed that the stent was not exiting the guide catheter and was getting close to the hub.Upon checking in the guide catheter, the device was fractured.The guide catheter, guidewire and stent was removed all together.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a synergy xd mr us 3.50 x 32mm stent delivery system was returned inserted through a 0.071 guide catheter.The crimped stent was exiting out through the guide.An examination of the exposed distal end of the synergy xd device, which was exiting out through the guide, noted a severe kink in the distal extrusion.An examination of the guide identified that the guide catheter was kinked and compressed at various locations along its length.The tip section of the guide was compressed and split/torn.Sections of the surface of the guide exhibited minor tears.The distal end of the synergy xd device was exiting out through the guide.When an attempt was made to withdraw the device from the sheath, the device was removed in two sections as a result of a break in the hypotube at 61.9cm distal to the strain relief.The distal section of the device (remaining section of hypotube, distal extrusion, balloon, crimped stent and tip was removed distally out through the guide with no resistance).A visual and microscopic examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A break was confirmed in the hypotube at 61.9cm distal to the strain relief.Both sections of the hypotube were kinked at various locations along their lengths.An examination of the exposed distal end of the synergy xd device, which was exiting out through the guide, noted a severe kink in the distal extrusion.The kink was located at 3cm distal to port.As a result of the kink, it was not possible to pass a 0.014inch size wire beyond the kink location.When the device was fully withdrawn from the guide, in two sections, no other damage was observed along the distal extrusion.No other issues were identified during the product analysis.

• 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: 13508642
• Report Number: 2134265-2022-01204
• Device Sequence Number: 5038766
• Product Code: NIQ
• UDI-Device Identifier: 08714729981084
• UDI-Public: 08714729981084
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 04/11/2022

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: 08/09/2023
• Device Model Number: H7493941832350
• Device Lot Number: 0027939436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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 Age: 58 YR
• Patient Sex: Female