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

Model Number	H7493941820350
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that stent fracture occurred.The patient presented with coronary artery disease (cad).A 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, the device was unable to cross the lesion and it was noticed that the stent struts broke.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
B3.Date of event- used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: the synergy xd 3.50 x 20 mm stent delivery system was returned for analysis.A visual examination of the stent found distal stent damage with struts pulled distally and lifted.The stent showed no signs of movement and was set between the proximal and distal markerbands.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon body was reviewed; no issues were noted on the balloon cones.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent fracture occurred.The patient presented with coronary artery disease (cad).A 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, the device was unable to cross the lesion and it was noticed that the stent struts broke.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• 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: 12440545
• Report Number: 2134265-2021-10769
• Device Sequence Number: 11965899
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: 08714729981053
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: 10/20/2022
• Device Model Number: H7493941820350
• Device Lot Number: 0026264197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1