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

Model Number 9554

Device Problems Fracture (1260); Failure to Advance (2524); Material Deformation (2976)

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

Event Date 04/02/2023

Event Type  malfunction  

Manufacturer Narrative

(e1) initial reporter facility name: (b)(6).(e1) initial reporter phone number: (b)(6).

Event Description

It was reported that stent fracture occurred.The target lesion was located in the severely tortuous and severely calcified, 40mm length with reference vessel diameter of 3.1mm orstal of left anterior descending artery.A 38 x 3.00 promus premier drug eluting stent was advanced to treat the lesion.However, during procedure, the stent was fractured and could not cross.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

(e1) initial reporter information: (b)(6).

Event Description

It was reported that stent fracture occurred.The target lesion was located in the severely tortuous and severely calcified, 40mm length with reference vessel diameter of 3.1mm orstal of left anterior descending artery.A 38 x 3.00 promus premier drug eluting stent was advanced to treat the lesion.However, during procedure, the stent was fractured and could not cross.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the stent material did not broke into pieces and was completely removed directly from the patient.

Event Description

It was reported that stent fracture occurred.The target lesion was located in the severely tortuous and severely calcified, 40mm length with reference vessel diameter of 3.1mm orstal of left anterior descending artery.A 38 x 3.00 promus premier drug eluting stent was advanced to treat the lesion.However, during procedure, the stent was fractured and could not cross.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the stent material did not broke into pieces and was completely removed directly from the patient.

Manufacturer Narrative

Device evaluated by mfr: promus premier ous mr 38 x 3.00mm stent delivery system was returned for analysis.Visual, tactile, microscopic and dimensional analysis was performed on the device.Multiple hypotube kinks were noted and the proximal section of the stent had damage.Multiple hypotube kinks were noted along the shaft of the device.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.Stent struts were lifted at proximal section of the device.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No signs of movement, stent was set between the proximal and distal markerbands.Bumper tip showed no signs of distal tip damage.The undamaged stent od was measured using snap gauge and the result was within max crimped stent profile measurement.(e1) (b)(6).

• 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: 16907395
• MDR Text Key: 314955341
• Report Number: 2124215-2023-22923
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2023

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 Expiration Date: 07/19/2023
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0027744357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 05/14/2023; 06/19/2023
• Supplement Dates FDA Received: 06/06/2023; 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 55 KG