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

Model Number 10662

Device Problem Failure to Advance (2524)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: promus premier select 12 x 3.50mm was returned to the complaint investigation site.Visual, tactile and microscopic analysis of the stent profile revealed that the balloon appeared to be pulled over the proximal end of the stent and struts were lifted.No issues identified with the hypotube shaft.Multiple kinks and a break were identified along the polymer extrusion of the device.Microscopic analysis revealed that the proximal balloon had been pulled and folded over the proximal section of the stent.The distal balloon wings were tightly wrapped and evenly folded.There were no signs the balloons had been subjected to positive pressure.Stent positioning revealed no signs of movement, stent was set between the proximal and distal markerbands.Multiple kinks and a break at 10cm distal to the distal end of the distal tip were identified along the polymer extrusion of the device.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.

Event Description

Reportable based on device analysis completed on 15-mar-2024.It was reported that crossing difficulties were encountered.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.The lesion was engaged with a 6f non-boston scientific (bsc) guide catheter, crossed with a wire and pre-dilated with a 3.0 x 10 semi-compliant balloon catheter.Following pre-dilatation, a 12 x 3.50 promus premier select drug-eluting stent was advanced but failed to cross the lesion.The device was removed intact, and the procedure was completed using a non-bsc device.No patient complications were reported, and the patient was stable post-procedure.However, returned device analysis revealed hypotube break.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18997068
• MDR Text Key: 338986679
• Report Number: 2124215-2024-18791
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10662
• Device Catalogue Number: 10662
• Device Lot Number: 0029562507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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: 58 YR
• Patient Sex: Male
• Patient Race: Asian