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

Model Number 9552

Device Problems Premature Activation (1484); Material Integrity Problem (2978)

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

Event Date 05/12/2023

Event Type  malfunction  

Manufacturer Narrative

(e1) initial reporter phone: (b)(6).

Event Description

It was reported that stent premature deployment occurred.During unpacking of a 28 x 2.50 promus premier drug-eluting stent, the tip of the stent was noticed to be expanded.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable following the procedure.

Manufacturer Narrative

(e1) initial reporter phone: (b)(6).

Event Description

It was reported that stent premature deployment occurred.During unpacking of a 28 x 2.50 promus premier drug-eluting stent, the tip of the stent was noticed to be expanded.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable following the procedure.It was further reported that the tip of the device was damaged and not prematurely deployed as what previously reported.

Manufacturer Narrative

Updated h6: device codes.(e1) initial reporter phone: (b)(6).Device evaluated at mfr.: the promus premier ous mr 28 x 2.50mm stent delivery system (sds) was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.Microscopic examination of the device identified tip damage with the distal area appearing uneven, confirming the reported event.No other device issues were identified during returned product analysis.

Event Description

It was reported that stent premature deployment occurred.During unpacking of a 28 x 2.50 promus premier drug-eluting stent, the tip of the stent was noticed to be expanded.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable following the procedure.It was further reported that the tip of the device was damaged and not prematurely deployed as what previously reported.

• 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: 17162357
• MDR Text Key: 317476805
• Report Number: 2124215-2023-30654
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9552
• Device Catalogue Number: 9552
• Device Lot Number: 0030604587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2022
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 89 KG