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

Model Number 9551

Device Problems Failure to Advance (2524); Material Integrity Problem (2978)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 20-feb-2024.It was reported that tip damage and crossing difficulties were encountered.The 70% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 24 x 3.00mm promus premier drug eluting stent was advanced for treatment but when the tip of the stent was inserted into the patient, the crossibility was very poor.When the device was taken out, the tip was noted to be kinked.The procedure was completed using a different device.There were no patient complications reported, and the patient status was stable.However, returned device analysis revealed hypotube break.

Manufacturer Narrative

E1: initial reporter phone: (b)(6).Device evaluated by mfr.: promus premier ous mr 24 x 3.00mm stent delivery system (sds) was returned for analysis.Visual, tactile and microscopic analysis and dimensional testing were performed on the device.A visual and tactile examination of the hypotube found a break at 40cm proximal to the distal bumper tip.No issues were identified with the outer / mid-shaft sections or the inner lumen of the device.Examination of the stent found stent damage with stent struts bunched/lifted at the mid 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.Bumper tip showed no signs of distal tip damage.The undamaged crimped stent outer diameter was measured by snap gauge and the result was within max crimped stent profile measurement.No other 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: 18827259
• MDR Text Key: 336906397
• Report Number: 2124215-2024-11094
• 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
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2024
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0028695718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 70 KG