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

Model Number	H7493941812220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2021 as an estimate based on aware date.
Event or Problem Description
It was reported that a shaft break occurred.While a 2.25 x 12mm synergy xd drug eluting stent was being advanced to cross a calcified lesion, the shaft broke.The device was removed and the procedure completed with another of the same device.There were no patient complications and the patient status was stable.
Event or Problem Description
It was reported that a shaft break occurred.While a 2.25 x 12mm synergy xd drug eluting stent was being advanced to cross a calcified lesion, the shaft broke.The device was removed and the procedure completed with another of the same device.There were no patient complications and the patient status was stable.It was further reported that the target lesion was located in the 70% stenosed and severely calcified artery.It was noted that the break was 3-5 cm from the hub and was completely removed from the patient's body manually.
Additional Manufacturer Narrative
Correction: b3 date of event reported (b)(6) 2021 as an estimate based on aware date.B3 updated to (b)(6) 2021.
Additional Manufacturer Narrative
Device evaluated by mfr: a synergy xd mr us 2.25 x 12mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found no issues with the stent.There were no signs 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 by snap gauge and the result was 0.0360 inch this is within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and tactile examination of the hypotube found multiple kinks and a break 23cm distal to the distal end of the strain relief.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and a tactile examination was performed.No issues were noted.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a shaft break occurred.While a 2.25 x 12mm synergy xd drug eluting stent was being advanced to cross a calcified lesion, the shaft broke.The device was removed and the procedure completed with another of the same device.There were no patient complications and the patient status was stable.It was further reported that the target lesion was located in the 70% stenosed and severely calcified artery.It was noted that the break was 3-5 cm from the hub and was completely removed from the patient's body manually.

• 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: 11583090
• Report Number: 2134265-2021-03302
• Device Sequence Number: 17217451
• Product Code: NIQ
• UDI-Device Identifier: 08714729980711
• UDI-Public: 08714729980711
• 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,Followup
• Report Date (Section B): 05/04/2021

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: 10/12/2022
• Device Model Number: H7493941812220
• Device Lot Number: 0026212038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 03/24/2021; 04/15/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/12/2021; 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1