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

Model Number 10664

Device Problem Failure to Deflate (4060)

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

Event Date 03/25/2023

Event Type  malfunction  

Event Description

It was reported that the balloon deflation issues occurred.A 20 x 3.00mm promus premier select was selected for use.The promus premier select was advanced to the lesion.The stent delivery balloon was inflated.The stent delivery balloon could not be deflated despite multiple attempts.The promus premier select stent delivery system was retrieved with the balloon and stent using an encore 26 inflation device.Another promus premier select was implanted.No patient complications occurred.

Manufacturer Narrative

B5 - updated describe event or problem.

Event Description

It was reported that the balloon deflation issues occurred.A 20 x 3.00mm promus premier select was selected for use.The promus premier select was advanced to the lesion.The stent delivery balloon was inflated.The stent delivery balloon could not be deflated despite multiple attempts.The promus premier select stent delivery system was retrieved with the balloon and stent using an encore 26 inflation device.Another promus premier select was implanted.No patient complications occurred.It was further reported that the target lesion was located in a non-tortuous and severely calcified left anterior descending (lad) artery.The balloon was inflated at 12 atmospheres and wanted to deflate the balloon directly.The balloon was still in an inflated state while it was removed and simply pulled everything out.

Manufacturer Narrative

Device evaluated by mfr.: a promus select ous mr 20 x 3.00mm stent delivery system; catheter was returned for analysis.The device was returned without the stent attached.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture.The balloon was reviewed, and it was found to be in a partially deflated state.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.A shaft break was identified 29.5cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found it to be flattened and damaged on its along the shaft polymer extrusion.Damage was noted on the inner polymer extrusion on the proximal section of the markerband on the balloon.The device could not be inflated due to the extensive damage along the polymer extrusion shaft which was flattened.An attempt was made to load a 0.014 inch guidewire however it would not pass the inner shaft polymer extrusion damage.No other issues were identified during the product analysis.

Event Description

It was reported that the balloon deflation issues occurred.A 20 x 3.00mm promus premier select was selected for use.The promus premier select was advanced to the lesion.The stent delivery balloon was inflated.The stent delivery balloon could not be deflated despite multiple attempts.The promus premier select stent delivery system was retrieved with the balloon and stent using an encore 26 inflation device.Another promus premier select was implanted.No patient complications occurred.It was further reported that the balloon was first inflated to 12atm to place the stent in the severely calcified, non-tourtous left anterior descending artery then the balloon was deflated.Post-dilation was performed at 2atm.The balloon did not deflate.The balloon was removed intact along with the catheter and guidewire.

• Brand Name: PROMUS PREMIER SELECT
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16663014
• MDR Text Key: 312591978
• Report Number: 2124215-2023-15356
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2023

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: 10664
• Device Catalogue Number: 10664
• Device Lot Number: 0030528929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 04/03/2023; 05/23/2023
• Supplement Dates FDA Received: 04/20/2023; 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2022
• 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