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

Model Number	H7493941828350
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the severely tortuous and severely calcified proximal circumflex artery.A 3.50 x 28mm synergy xd drug-eluting stent was advanced to treat the lesion.However, the synergy xd drug-eluting stent could not be implanted.The synergy xd drug-eluting stent delivery system was removed and the shaft broke into two pieces outside the patient's body.The procedure was completed with 3.5 x 24mm synergy stent with the use of a guide extension catheter.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the severely tortuous and severely calcified proximal circumflex artery.A 3.50 x 28mm synergy xd drug-eluting stent was advanced to treat the lesion.However, the synergy xd drug-eluting stent could not be implanted.The synergy xd drug-eluting stent delivery system was removed and the shaft broke into two pieces outside the patient's body.The procedure was completed with 3.5 x 24mm synergy stent with the use of a guide extension catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.50 x 28mm stent delivery system (sds) was returned for analysis.A visual 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 markerbands.The stent outer diameter was measured and the result was within max 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 distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks and a break 21.75 cm distal to the strain relief.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during 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
• MDR Report Key: 11779664
• Report Number: 2134265-2021-05649
• Device Sequence Number: 17201262
• Product Code: NIQ
• UDI-Device Identifier: 08714729981077
• UDI-Public: 08714729981077
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 12/16/2022
• Device Model Number: H7493941828350
• Device Lot Number: 0026577750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1