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

Model Number	H7493941816400
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered and shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left main coronary artery.After rotational atherectomy was performed with a rotawire, a 4.00 x 16mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.The device was removed and when the stent catheter was outside the patient's body, it would not come off of the rota floppy wire.More force was applied to remove the stent and it broke.A non-boston scientific wire was inserted and a 4.0x12 synergy xd drug-eluting stent was successfully deployed.There were no complications reported and the patient was fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 16mm stent delivery system catheter 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 within maximum crimped stent profile measurement.The balloon cones were reviewed.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.There was a blood like substance visible in the cones.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube found no issues with the hypotube or hub profile.A visual and tactile examination of the outer and inner lumen and mid-shaft section found inner extrusion break at 5cm distal of port bond.Shaft polymer extrusion break at 8cm proximal of the tip.The shaft polymer extrusion is damaged, stretched and outer extrusion torn in some sections.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that removal difficulties were encountered and shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left main coronary artery.After rotational atherectomy was performed with a rotawire, a 4.00 x 16mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.The device was removed and when the stent catheter was outside the patient's body, it would not come off of the rota floppy wire.More force was applied to remove the stent and it broke.A non-boston scientific wire was inserted and a 4.0x12 synergy xd drug-eluting stent was successfully deployed.There were no complications reported and the patient was fully recovered.

• 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: 11003167
• Report Number: 2134265-2020-17485
• Device Sequence Number: 703919
• Product Code: NIQ
• UDI-Device Identifier: 08714729981121
• UDI-Public: 08714729981121
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/17/2021

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: 06/22/2022
• Device Model Number: H7493941816400
• Device Lot Number: 0025654165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 11/28/2020
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1