MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING

Model Number 9554

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

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The 80% stenosed target lesion was located in the severely tortuous and mildly calcified left circumflex artery.Following pre-dilation with 2.5 x 15 balloon catheter, a 38 x 3.00 promus premier drug-eluting stent was advanced but failed to track due to the severe tortuosity of the lesion.However, during procedure, the shaft broke inside the patient.The procedure was completed using another stent.No patient complications were reported, and the patient was stable post-procedure.

Manufacturer Narrative

Device evaluated by mfr.: promus premier 38 x 3.00mm stent delivery system was returned to the cis for analysis.Visual, tactile and microscopic analysis was performed on the device.There was no sign of damage, stretching or lifting of the stent struts.No signs of movement, stent was set between the proximal and distal markerbands.Examination of the hypotube shaft identified a break at 21cm distal to the distal end of the strain relief along the length of the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.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.

Event Description

It was reported that shaft break occurred.The 80% stenosed target lesion was located in the severely tortuous and mildly calcified left circumflex artery.Following pre-dilation with 2.5 x 15 balloon catheter, a 38 x 3.00 promus premier drug-eluting stent was advanced but failed to track due to the severe tortuosity of the lesion.However, during procedure, the shaft broke inside the patient.The procedure was completed using another stent.No patient complications were reported, and the patient was stable post-procedure.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 18405160
• MDR Text Key: 331723357
• Report Number: 2124215-2023-74025
• 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,Followup
• Report Date: 01/05/2024

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: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0030771287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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