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

Model Number	H7493941824300
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
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 damage occurred.During the intention to cross the lesion, a guide extension was placed.A 3.00 x 24mm synergy xd stent was advanced for treatment.However, the stent became stuck inside and the struts were damaged.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported, that stent damage occurred.During the intention to cross the lesion, a guide extension was placed.A 3.00 x 24mm synergy xd stent was advanced for treatment.However, the stent became stuck inside and the struts were damaged.The procedure was completed with a different device.No patient complications were 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 evaluation by mfr.: the synergy xd mr us 3.00 x 24mm stent delivery system 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 marker bands.The crimped stent outer diameter was measured.And 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 no issues.A visual examination of the outer and inner lumen and mid-shaft section, found no issues along the shaft polymer extrusion.A test guidewire loaded successfully.No 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: 11731162
• Report Number: 2134265-2021-04968
• Device Sequence Number: 4027248
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: 08714729980988
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 10/27/2022
• Device Model Number: H7493941824300
• Device Lot Number: 0026278622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1