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

Model Number H7493941828250

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2021

Event Type  malfunction  

Event Description

It was reported that stent moved on balloon was encountered.A 2.50 x 28mm synergy xd drug eluting stent was selected for preparation.However there was bend right behind the balloon and the stent moved on the balloon.The procedure was completed successfully.The device was not used for this procedure.There were no patient complications reported.

Event Description

It was reported that stent moved on balloon was encountered.A 2.50 x 28mm synergy xd drug eluting stent was selected for preparation.However there was bend right behind the balloon and the stent moved on the balloon.The procedure was completed successfully.The device was not used for this procedure.There were no patient complications reported.It was further reported that the stent was damaged and not fully on the balloon.

Event Description

It was reported that stent moved on balloon was encountered.A 2.50 x 28mm synergy xd drug eluting stent was selected for preparation.However there was bend right behind the balloon and the stent moved on the balloon.The procedure was completed successfully.The device was not used for this procedure.There were no patient complications reported.It was further reported that the stent was damaged and not fully on the balloon.

Manufacturer Narrative

Device evaluated by mfr.: synergy xd mr us 2.50 x 28mm stent delivery system (sds) was returned for analysis.Examination of the crimped stent via scope found stent damage.Stent struts on the proximal end were flared.The stent showed no signs of movement and was set between the proximal and distal markerbands.The undamaged crimped stent outer diameter was measured by snap gauge and the result was within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon returned deflated and the proximal balloon cone appeared bunched.A visual and tactile examination of the hypotube found multiple kinks.Examination of the tip via scope found damage to the tip.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12617391
• MDR Text Key: 276381935
• Report Number: 2134265-2021-12775
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: 08714729980834
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: H7493941828250
• Device Lot Number: 0027262394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1