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

Model Number 10623

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter phone: (b)(6).

Event Description

It was reported that shaft break occurred.The 70% stenosed, 35mmx2.75mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.75 x 38 synergy drug eluting stent was advanced for treatment.However, during the procedure, it was noted that the shaft was kinked and was fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

D4: batch/lot number updated from 0030732765 to 0030260155.E1: initial reporter phone: (b)(6).

Event Description

It was reported that shaft break occurred.The 70% stenosed, 35mmx2.75mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.75 x 38 synergy drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the shaft was kinked and was fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

• 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: 18735848
• MDR Text Key: 336422050
• Report Number: 2124215-2024-09355
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• 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: 0030260155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 89 KG