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

Model Number 10623

Device Problem Break (1069)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: as the event date was not reported, the first day in the month of the aware date is provided.

Event Description

It was reported that shaft break occurred.A 3.00 x 38 synergy xd drug-eluting stent was used for treatment.However, during preparation of the device, while pulling the device out of the box, the proximal shaft broke.The device was replaced with another stent and the procedure was completed.There were no patient complications reported.

Manufacturer Narrative

B5 event description: corrected "synergy xd" to "synergy".B3: as the event date was not reported, the first day in the month of the aware date is provided.

Event Description

It was reported that shaft break occurred.A 3.00 x 38 synergy xd drug-eluting stent was used for treatment.However, during preparation of the device, while pulling the device out of the box, the proximal shaft broke.The device was replaced with another stent and the procedure was completed.There were no patient complications reported.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18932830
• MDR Text Key: 338089550
• Report Number: 2124215-2024-15536
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0030040211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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