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

Lot Number 0025358565

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first day of the month of aware date, as event date was not provided.

Event Description

It was reported that stent damage occurred.A 3.00 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure it was noted that the tip of the stent was damaged.The procedure was completed with different device.There were no patient complications nor injuries reported.

Manufacturer Narrative

B3 - date of event: used the first day of the month of aware date, as event date was not provided.

Event Description

It was reported that stent damage occurred.A 3.00 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure it was noted that the tip of the stent was damaged.The procedure was completed with different device.There were no patient complications nor injuries reported.It was further reported that it was the tip of the catheter that was damaged.

• 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: 13999290
• MDR Text Key: 288661637
• Report Number: 2134265-2022-03872
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2022
• Device Lot Number: 0025358565
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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