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

Model Number 9553

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 01/26/2024

Event Type  malfunction  

Event Description

It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery (lcx) with 32mm length and 3.0 diameter.A 32 x 3.00 promus premier drug-eluting stent was advanced for treatment.During withdrawal, the stent became detached within the delivery shaft.The detached stent was simply pulled out and the procedure was completed with another of the same device.There were no patient complications reported, and the patient condition was stable post-procedure.

Manufacturer Narrative

Initial reporter phone: (b)(6).

Event Description

It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery (lcx) with 32mm length and 3.0 diameter.A 32 x 3.00 promus premier drug-eluting stent was advanced for treatment.During withdrawal, the stent became detached within the delivery shaft.The detached stent was simply pulled out and the procedure was completed with another of the same device.There were no patient complications reported, and the patient condition was stable post-procedure.

Manufacturer Narrative

Initial reporter phone: (b)(4).Device evaluated by manufacturer: promus premier ous mr 32 x 3.00mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination stent profile identified stent struts lifted at the proximal end of the stent and stent struts dented at the mid-section of the stent.Visual and tactile inspection of hypotube profile revealed no issues were noted along the shaft of the device.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.Microscopic analysis of the 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.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: 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: 18804250
• MDR Text Key: 336625679
• Report Number: 2124215-2024-11634
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0031322317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 73 KG