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

Model Number	H7493941824300
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, after the stent was loaded on the wire and advanced, the physician noticed that the stent didn't look fully crimped on the balloon.The procedure was completed and there were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, after the stent was loaded on the wire and advanced, the physician noticed that the stent didn't look fully crimped on the balloon.The procedure was completed and there were no patient complications nor injuries reported.It was further reported that the some of the stent struts were elevated.The procedure was completed with another of same device.
Additional Manufacturer Narrative
(b5) - updated describe event or problem.
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, after the stent was loaded on the wire and advanced, the physician noticed that the stent didn't look fully crimped on the balloon.The procedure was completed and there were no patient complications nor injuries reported.It was further reported that some of the stent struts were elevated.The procedure was completed with another of same device.
Additional Manufacturer Narrative
B5.Describe event or problem updated.Device evaluated by mfr.: a synergy xd mr us 3.00 x 24mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage with struts on the distal end in a lifted state.The undamaged crimped stent outer diameter was measured and the result was within maximum 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 damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product 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: 11452267
• Report Number: 2134265-2021-03099
• Device Sequence Number: 4049023
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: 08714729980988
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 06/10/2021

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: 06/08/2022
• Device Model Number: H7493941824300
• Device Lot Number: 0025608340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 03/18/2021; 05/20/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/06/2021; 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1