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

Model Number 9550

Device Problem Difficult to Advance (2920)

Patient Problem Chest Pain (1776)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter phone: (b)(6).

Event Description

It was reported that patient experienced chest pain.A 20 x 2.75 promus premier drug-eluting stent (des) was selected for treatment.During procedure, the catheter failed to advance inside the patient and the patient chest pain intensifies.The procedure was completed with a different device.There were no further patient complications reported.

Event Description

It was reported that patient experienced chest pain.A 20 x 2.75 promus premier drug-eluting stent (des) was selected for treatment.During procedure, the catheter failed to advance inside the patient and the patient chest pain intensifies.The procedure was completed with a different device.There were no further patient complications reported.

Manufacturer Narrative

E1: initial reporter phone: (b)(6).Device evaluated by mfr: a 20 x 2.75 mm promus premier stent delivery system (sds) was returned for analysis.Visual, tactile and functional analysis was performed on the device.Visual examination and microscopic analysis of stent profile identified no issues.There was no sign of damage, stretching or lifting of the stent struts.No issues identified with the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Bumper tip showed no signs of distal tip damage.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The device was successfully tracked through a recommended 0.014'' guidewire with no issues.No device issues were identified during returned product analysis.

• 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: 17594929
• MDR Text Key: 321633557
• Report Number: 2124215-2023-41963
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9550
• Device Catalogue Number: 9550
• Device Lot Number: 0030242074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2022
• 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 Outcome(s): Other