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

Model Number 9554

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

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that labelling issue occurred.The patient underwent percutaneous coronary intervention.The 82% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 38 x 3.50 promus premier drug-eluting stent was advanced but failed to cross the lesion.However, after using the device, the physician noticed that the batch number of the inner packaging was different from that of the outer packaging and the batch number on the handle was different from the package.Both packaging has the same size.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).Device evaluated by mfr: the promus premier 38/3.50mm was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal 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 showed no signs of distal tip 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.

Event Description

It was reported that labelling issue occurred.The patient underwent percutaneous coronary intervention.The 82% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 38 x 3.50 promus premier drug-eluting stent was advanced but failed to cross the lesion.However, after using the device, the physician noticed that the batch number of the inner packaging was different from that of the outer packaging and the batch number on the handle was different from the package.Both packaging has the same size.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• 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: 16421713
• MDR Text Key: 310049292
• Report Number: 2124215-2023-05436
• 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: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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: 0029821259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2022
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 63 KG