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

Model Number 10619

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 20mm was returned to the complaint investigation site.Visual, tactile and microscopic analysis revealed multiple kinks and a break at 18cm distal to the distal end of the strain relief were identified along the hypotube shaft of the device.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Visual examination identified the stent had damage at the distal section.Microscopic examination of the crimped stent via scope found evidence of stent damage with stent stretched & lifted at the distal section.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No signs of movement, stent was set between the proximal and distal markerbands.Bumper tip showed no signs of distal tip damage.Dimensional analysis included measurement of the undamaged crimped stent outer diameter and the result was within max crimped stent profile measurement.No other issues were identified during 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: 18993285
• MDR Text Key: 338817321
• Report Number: 2124215-2024-16879
• 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 Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0030087585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• 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