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

Model Number 9554

Device Problem Break (1069)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).

Event Description

It was reported that shaft break occurred.The 78% stenosed, 2.75x38mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 38 x 2.75mm promus premier drug-eluting stent was selected for treatment.However, it was noted that the stent rod was fractured and could not be used.The procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable.

Manufacturer Narrative

(b)(6).

Event Description

It was reported that shaft break occurred.The 78% stenosed, 2.75x38mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 38 x 2.75mm promus premier drug-eluting stent was selected for treatment.However, it was noted that the stent rod was fractured and could not be used.The procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable.It was further reported that the shaft of the device was broken at 40cm from the hub.

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).Device evaluated by mfr.: promus premier ous mr 38 x 2.75mm stent delivery system (sds) was returned to the complaint investigation site (cis).Multiple kinks and a break was identified on the hypotube shaft.The break was noted to be 32cm distal to the distal end of the strain relief.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.Visual examination of the stent identified a stent strut lifted at the proximal section of the stent.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 issues were noted with the bumper tip.The undamaged stent outer diameter was measured using snap gauge and the result was within max crimped stent profile measurement.

Event Description

It was reported that shaft break occurred.The 78% stenosed, 2.75x38mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 38 x 2.75mm promus premier drug-eluting stent was selected for treatment.However, it was noted that the stent rod was fractured and could not be used.The procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable.It was further reported that the shaft of the device was broken at 40cm from the hub.

• 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: 18510946
• MDR Text Key: 333157772
• Report Number: 2124215-2024-01581
• 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,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0031948199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 86 KG