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

Model Number 9548

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/15/2024

Event Type  malfunction  

Event Description

It was reported that the stent moved on the balloon.A 12 x 3.50 promus premier drug-eluting stent was selected for treatment.During the procedure, it was noted that the device had a loose stent making it impossible to use in the patient.No patient complications were reported.

Event Description

It was reported that the stent moved on the balloon.A 12 x 3.50 promus premier drug-eluting stent was selected for treatment.During the procedure, it was noted that the device had a loose stent making it impossible to use in the patient.No patient complications were reported.

Manufacturer Narrative

The promus premier ous mr 12 x 3.50mm stent delivery system was returned for analysis.Visual and tactile inspection of the hypotube found multiple kinks and a break at 21.5cm distal to the distal end of the strain relief, but no issues with the outer/mid-shaft sections or inner lumen of the device.Microscopic inspection revealed stent struts lifted at the proximal section and no signed of stent movement on the balloon.No balloon issues were noted, and the balloon had not been subjected to positive pressure.There was no tip damage.The undamaged crimped stent od (outer diameter) was measured within max crimped stent profile measurement.No other device issues were identified during returned product analysis.

• 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
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18908849
• MDR Text Key: 337745438
• Report Number: 2124215-2024-15584
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: 05/29/2024

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: 9548
• Device Catalogue Number: 9548
• Device Lot Number: 0030669524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• 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: 73 YR