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

Model Number 9551

Device Problems Failure to Advance (2524); Device Markings/Labelling Problem (2911); Wrong Label (4073)

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

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that a labelling issue occurred.The 89% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery.A 24 x 3.00 promus premier drug-eluting stent was advanced but failed to cross the lesion.It was also noted that the label on the internal packaging indicated a different batch number than the label on the external packaging.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

E1: (b)(6).Device evaluated by mfr.: promus premier ous mr 24 x 3.00mm stent delivery system, catheter was returned for analysis.A visual examination of the crimped stent identified no damage.The stent was securely crimped between both markerbands.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip identified no damage.A visual and tactile examination of the hypotube shaft found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No issues were identified during analysis.Additionally, upon analysis it was noted that no issue had occurred with the labelling.A review of the images identified the manifold catheter batch 30364338.It is noted that this catheter batch is consumed under finished goods batch 30382217.This is not a labelling issue.There can be numerous batches consumed under the same finished goods batch.A dhr review confirmed that lot # 30364338 was a catheter batch that consumed with fgb# 30382217 and thus printed on the hub of the device.

Event Description

It was reported that a labelling issue occurred.The 89% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery.A 24 x 3.00 promus premier drug-eluting stent was advanced but failed to cross the lesion.It was also noted that the label on the internal packaging indicated a different batch number than the label on the external packaging.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the batch number at the end of the handle was inconsistent with that of the outer packaging.

• 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: 16778844
• MDR Text Key: 314028995
• Report Number: 2124215-2023-15720
• 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
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0030382217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 53 KG