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

Model Number 9553

Device Problems Failure to Advance (2524); Wrong Label (4073)

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

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

E1- initial reporter address 1: (b)(6).

Event Description

It was reported that a labelling issue occurred.The patient underwent percutaneous coronary intervention (pci) of the 82% stenosed target lesion located in the severely tortuous and severely calcified left circumflex (lcx) artery.A 32 x 3.00mm promus premier drug-eluting stent was advanced for treatment 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.No damage to the package prior to opening was noted.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that a labelling issue occurred.The patient underwent percutaneous coronary intervention (pci) of the 82% stenosed target lesion located in the severely tortuous and severely calcified left circumflex (lcx) artery.A 32 x 3.00mm promus premier drug-eluting stent was advanced for treatment 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.No damage to the package prior to opening was noted.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 batch number of the label was found to be inconsistent with the batch number of the device itself when the complaint was reported.The device itself was not marked with the size.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).

Manufacturer Narrative

(b)(6).Device evaluated by mfr.: promus premier ous mr 32 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 a kink 4.5cm distal to the distal end of the strain relief.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 other issues were identified during analysis.

Event Description

It was reported that a labelling issue occurred.The patient underwent percutaneous coronary intervention (pci) of the 82% stenosed target lesion located in the severely tortuous and severely calcified left circumflex (lcx) artery.A 32 x 3.00mm promus premier drug-eluting stent was advanced for treatment 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.No damage to the package prior to opening was noted.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 batch number of the label was found to be inconsistent with the batch number of the device itself when the complaint was reported.The device itself was not marked with the size.

• 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: 16778823
• MDR Text Key: 314023886
• Report Number: 2124215-2023-15719
• 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: 06/15/2023

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: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0030203944
• 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: 09/14/2022
• 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: 60 KG