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

Model Number 10618

Device Problem Break (1069)

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

Event Date 11/25/2023

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The 10% stenosed target lesion was located in the mildly tortuous and mildly calcified coronary vessel.A 2.75 x 16 synergy ii drug-eluting stent was advanced to treat the lesion.Upon insertion, it was noticed that the shaft was fractured.The fractured device was removed.The procedure was completed with other device and there were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 2.75 x 16mm stent delivery system catheter was returned for analysis.Visual, tactile and microscopic analysis were performed on the device.Examination of the hypotube found a multiple kinks and breaks at 14cm, 25.7cm and 40.9cm distal to the distal end of the strain relief, 100.5cm from the distal markerband.Multiple kinks were identified along the polymer extrusion shaft.Examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.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.No other device issues were identified during returned product analysis.

Event Description

It was reported that shaft break occurred.The 10% stenosed target lesion was located in the mildly tortuous and mildly calcified coronary vessel.A 2.75 x 16 synergy ii drug-eluting stent was advanced to treat the lesion.Upon insertion, it was noticed that the shaft was fractured.The fractured device was removed.The procedure was completed with other device and there were no patient complications reported.

• 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: 18346676
• MDR Text Key: 330736397
• Report Number: 2124215-2023-71006
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0030514538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• 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