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

Model Number	H7493941820500
Medical Device Problem Codes	Break (1069); Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties, device detachment and additional intervention occurred.A guidezilla ii guide extension catheter was advanced to the target lesion in the mid right coronary artery (rca) which was noted to be very large.A 5.00 x 20mm synergy balloon expandable stent was advanced and the stent was successfully deployed.During removal of the synergy stent delivery system back into the guidezilla ii, the catheter became stuck.The guidezilla ii, synergy delivery system catheter and guidewire were all removed as one unit.8cm of the synergy stent delivery system broke off inside the patient near the distal sheath tip.The detached portion was successfully removed using a snare.The procedure was completed and the patient fully recovered.
Event or Problem Description
It was reported that removal difficulties, device detachment and additional intervention occurred.A guidezilla ii guide extension catheter was advanced to the target lesion in the mid right coronary artery (rca) which was noted to be very large.A 5.00 x 20mm synergy balloon expandable stent was advanced and the stent was successfully deployed.During removal of the synergy stent delivery system back into the guidezilla ii, the catheter became stuck.The guidezilla ii, synergy delivery system catheter and guidewire were all removed as one unit.A 8cm of the synergy stent delivery system broke off inside the patient near the distal sheath tip.The detached portion was successfully removed using a snare.The procedure was completed and the patient fully recovered.It was further reported that there was no visual damage to the guidezilla.It was not clear where the delivery system was stuck, the stent catheter was pulled back after stenting and then felt stuck.Also, it was indicated that the device was completely removed as it was confirmed that there were no device fragments left in the patient's body per x-ray.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was returned without the stent as it was implanted at the lesion site.The balloon cones were reviewed, and signs of positive pressure applied to them were noted as the balloon folds were noted to be relaxed and crimp stent markings were visible on the balloon body.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found an inner shaft stretched 6.5 cm proximal to distal tip as well as a break at the exchange port region measured at 26 cm from distal tip.Additionally, a kink was noted on the shaft polymer extrusion at the proximal balloon bond.
Event or Problem Description
It was reported that removal difficulties, device detachment and additional intervention occurred.A guidezilla ii guide extension catheter was advanced to the target lesion in the mid right coronary artery (rca) which was noted to be very large.A 5.00 x 20mm synergy balloon expandable stent was advanced and the stent was successfully deployed.During removal of the synergy stent delivery system back into the guidezilla ii, the catheter became stuck.The guidezilla ii, synergy delivery system catheter and guidewire were all removed as one unit.A 8cm of the synergy stent delivery system broke off inside the patient near the distal sheath tip.The detached portion was successfully removed using a snare.The procedure was completed and the patient fully recovered.It was further reported that there was no visual damage to the guidezilla.It was not clear where the delivery system was stuck, the stent catheter was pulled back after stenting and then felt stuck.Also, it was indicated that the device was completely removed as it was confirmed that there were no device fragments left in the patient's body per x-ray.

• 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: 13307937
• Report Number: 2134265-2022-00478
• Device Sequence Number: 11584241
• Product Code: NIQ
• UDI-Device Identifier: 08714729981268
• UDI-Public: 08714729981268
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 03/22/2022

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: 06/22/2022
• Device Model Number: H7493941820500
• Device Lot Number: 0025648746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 01/19/2022; 03/02/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 02/08/2022; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown