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

Model Number 9548

Device Problems Positioning Failure (1158); Device Dislodged or Dislocated (2923)

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

Event Date 05/17/2023

Event Type  malfunction  

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 12 x 2.50 promus premier drug-eluting stent was advanced for treatment.However, during withdrawal, the stent was dislodged.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable after the procedure.

Manufacturer Narrative

Device evaluated by mfr.The device was returned to the cis for analysis.Visual, tactile, microscopic, dimensional and functional analysis was performed on the device.No device issues were identified during returned product analysis.The device was inflated to rated burst pressure and the stent deployed with no issues.

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).A 12 x 2.50 promus premier drug-eluting stent was advanced for treatment.However, during withdrawal, the stent was dislodged.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable after the procedure.It was further reported the stent could not be expanded again after implantation, so the stent was removed.The stent was dislodged in the middle segment of lad and was simply removed from the patient.

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).A 12 x 2.50 promus premier drug-eluting stent was advanced for treatment.However, during withdrawal, the stent was dislodged.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable after the procedure.It was further reported the stent could not be expanded again after implantation, so the stent was removed.The stent was dislodged in the middle segment of lad and was simply removed from the patient.

Manufacturer Narrative

Updated h6: device codes.

• 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: 17075362
• MDR Text Key: 316642631
• Report Number: 2124215-2023-26822
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9548
• Device Catalogue Number: 9548
• Device Lot Number: 0030487187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 53 KG