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

Model Number 9549

Device Problems Material Rupture (1546); Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 02/04/2023

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).

Event Description

It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 80% stenosed, concentric, de novo target lesion was located in the non-tortuous and mildly calcified left circumflex artery.The lesion included a bend between 45 and 90 degrees.The lesion was crossed with a non-boston scientific (non-bsc) guide catheter and two non-bsc guidewires.After the lesion was pre-dilated with a 3.00 x 20 mm nc emerge balloon catheter, a 16 x 4.00 promus premier drug-eluting stent was introduced, but had difficulty advancing.During the procedure, the stent balloon became perforated and damaged the stent.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

• 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: 18445626
• MDR Text Key: 331918418
• Report Number: 2124215-2023-74008
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: EG
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2023
• Device Model Number: 9549
• Device Catalogue Number: 9549
• Device Lot Number: 0027865126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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 Weight: 86 KG