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

Model Number 10617

Device Problems Break (1069); Failure to Advance (2524)

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

Event Date 10/10/2023

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad) and obtuse marginal artery.A 2.50 x 48 synergy drug-eluting stent (des) was advanced in mid-distal lad.However, during the procedure, it failed to cross the lesion and the shaft was broken inside patient.The device was removed and tried to cross again with a 2.25 x 20 synergy des and a 2.25 x 12 synergy des, but also failed to cross the lesion and the shaft of the two devices were also broken inside the patient.Both devices were removed, and percutaneous old balloon angioplasty was performed with a 1.50 x 09mm maverick balloon catheter to complete the procedure.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 2.25 x 12mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis revealed no sign of damage, stretching or lifting of the stent struts.A visual and tactile examination of the hypotube shaft identified a break at 17.5cm distal to the distal end of the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic analysis of stent positioning revealed no signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.

• 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: 18998901
• MDR Text Key: 339145689
• Report Number: 2124215-2024-18918
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2024
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0028792072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• 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: 59 YR
• Patient Sex: Female
• Patient Race: Asian