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

Model Number 10619

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

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that shaft kink occurred.During preparation of a 4.00 x 20mm synergy drug-eluting stent, the catheter was noted to be kinked and could not be delivered.The procedure was completed with another of the same device.There were no patient complications reported, and the patient was stable.However, returned device analysis revealed hypotube break.

Manufacturer Narrative

(b)(6).Device evaluated by mfr.: synergy ous mr 4.00 x 20mm was returned for analysis.A visual tactile and microscopic examination of the returned device confirmed that there was a break in the hypotube.The proximal section of the break, including the hub/manifold was not returned with the device.The break location measured 120cm proximal from the guidewire exit site.No kinks or damages were noted along the main section of the hypotube.A visual and tactile examination of the distal extrusion identified a break/dissection at 17.5cm distal to the guidewire exit site.The distal section of the break/dissection, including the balloon, crimped stent and tip was not returned with the device.A microscopic examination of the break site in the hypotube, identified no issues with the device which could have contributed to the break.A microscopic examination of the distal extrusion identified a break/dissection at 17.5cm distal to the guidewire exit site.No other damage was present.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone: (b)(6).Device evaluated by mfr.: synergy ous mr 4.00 x 20mm was returned for analysis.A visual and tactile examination identified a break in the hypotube.The proximal section of the break, including the hub/manifold was not returned with the device.The break location measured 120cm proximal from the guidewire exit site.No kinks or damages were noted along the main section of the hypotube.A visual and tactile examination of the distal extrusion identified a break/dissection at 17.5cm distal to the guidewire exit site.The distal section of the break/dissection, including the balloon, crimped stent and tip was not returned with the device.A microscopic examination of the break site in the hypotube, identified no issues with the device which could have contributed to the break.A microscopic examination of the distal extrusion identified a break/dissection at 17.5cm distal to the guidewire exit site.No other damage was present.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that shaft kink occurred.During preparation of a 4.00 x 20mm synergy drug-eluting stent, the catheter was noted to be kinked and could not be delivered.The procedure was completed with another of the same device.There were no patient complications reported, and the patient was stable.However, returned device analysis revealed hypotube break.It was further reported that the device was fractured right before deployment inside the patient and was removed with a snare.

• 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: 18393457
• MDR Text Key: 331342870
• Report Number: 2124215-2023-73511
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0029785956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 58 KG