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

Model Number 9551

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that the stent moved on the balloon.The 80% stenosed, 24 mm x 3.50 mm, target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 24 x 3.50 promus premier drug-eluting stent was advanced to treatment.However, there was resistance encountered advancing the device in the non- boston scientific guide catheter, and the stent moved from the balloon.The stent was remained on the stent delivery system (sds), but it was already loose.During removal, there were a resistance when the stent pulled back into the guide catheter.The device was slowly pulled back into the guide catheter and successfully removed.The procedure was completed successfully using a non-boston scientific device.There were no patient complications reported, and the patient was stable post-procedure.

Event Description

It was reported that the stent moved on the balloon.The 80% stenosed, 24 mm x 3.50 mm, target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 24 x 3.50 promus premier drug-eluting stent was advanced to treatment.However, there was resistance encountered advancing the device in the non- boston scientific guide catheter, and the stent moved from the balloon.The stent was remained on the stent delivery system (sds), but it was already loose.During removal, there were a resistance when the stent pulled back into the guide catheter.The device was slowly pulled back into the guide catheter and successfully removed.The procedure was completed successfully using a non-boston scientific device.There were no patient complications reported, and the patient was stable post-procedure.

Manufacturer Narrative

Device evaluated by mfr.: a 4 x 3.50 promus premier stent delivery system (sds) was returned for analysis.Visual, tactile, microscopic, dimensional and device-to-device interaction analysis was performed on the device.Multiple kinks were noted along the hypotube shaft.There were no damages/ kinks on shaft polymer extrusion.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.There were no signs of movement, stent was set between the proximal and distal markerbands.Bumper tip showed no signs of distal tip damage.The undamaged stent outer diameter was measured using snap gauge and the result was within max crimped stent profile measurement.The device could be loaded on a 0.0140-inch test guidewire and a 6f guide catheter without issues.Inspection of the remainder of the device, revealed no damage or irregularities.

• 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: 18632041
• MDR Text Key: 334545636
• Report Number: 2124215-2024-05935
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0031395363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2023
• 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
• Treatment: 0.014 RUNTHROUGH GUIDEWIRE - TERUMO.; 0.014 RUNTHROUGH GUIDEWIRE - TERUMO.