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

Model Number 9549

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

It was reported that removal difficulties were encountered.A 2.50x12mm balloon was predilated and 16 x 2.50 promus premier stent was selected for use.However, during procedure, the stent got stuck in the catheter path.The physician forced to withdraw the stent, but it was totally crushed that made the balloon broke, split in the middle segment, and they took it out in 2 parts.

Manufacturer Narrative

Device evaluated by manufacturer: promus premier ous mr 16 x 2.50mm stent delivery system was returned for analysis.The following attributes were examined.The stent was received detached from the delivery device.The stent was stretched and flattened.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture was 0.0389''.This is within max crimped stent profile measurement as per document specification 0.048''.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.There was clear evidence of stent crimp marks on the balloon.A visual and microscopic examination of the bumper tip found no issues.A visual and tactile examination of the hypotube found multiple kinks.A visual and tactile examination identified no kinks or damages in the distal extrusion.Using a recommended 0.0140" size test guidewire, the guide was inserted through the wire lumen of the device with no restrictions noted.The device was then inserted through a recommended size 5 french guide catheter.

Event Description

It was reported that removal difficulties and shaft break occurred.The target lesion was predilated with a 2.50x12mm balloon.The 2.5x16mm promus premier advanced and couldn't pass through the 6f guide catheter.The promus premier stent was withdrawn with force, the stent detached from the delivery system and was expanded and crushed.The stent delivery balloon catheter was split in the middle segment of the catheter in two pieces.No patient complications were reported.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 15925492
• MDR Text Key: 307785696
• Report Number: 2124215-2022-51002
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: EC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9549
• Device Catalogue Number: 9549
• Device Lot Number: 0029734942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2022
• 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