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

Model Number 10622

Device Problem Failure to Advance (2524)

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

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).Device evaluated by mfr.: synergy ous mr 3.00 x 32mm stent delivery system was returned for analysis.A visual examination of the stent found distal stent damage with strut lifted.The undamaged stent outer diameter was measured using snap gauge within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found a shaft break at approx.119.5cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.

Event Description

Reportable based on device analysis completed on (b)(6) 2022.It was reported that crossing difficulties were encountered.The patient presented with coronary artery disease and underwent percutaneous transluminal coronary angioplasty.The 70% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.After a 6f guide catheter was engaged, pre-dilation was performed with a 2.00 x 12 mm balloon.A 3.00 x 32 synergy drug-eluting stent was advanced but failed to cross the lesion.The device was removed intact, and the procedure was completed with a non-boston scientific device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed a shaft break.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16054010
• MDR Text Key: 308266628
• Report Number: 2124215-2022-54246
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0028747685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• 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
• Treatment: GUIDE CATHETER - 6F.
• Patient Sex: Female
• Patient Race: Asian