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

Model Number 10663

Device Problems Device Markings/Labelling Problem (2911); Wrong Label (4073)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

It was reported that a labeling issue occurred.During procedure preparation, a device with package label of promus premier select 2.75x16 was selected for use.However, after opening the package, the stent itself was noted to be 4.0x20 in size.There was no anomaly noted with the packaging prior to use.A replacement device of the correct size was selected to complete the procedure.There were no patient complications reported.

Manufacturer Narrative

Device history record review: a device history records (dhr) review was performed for the promus premier select referenced batch (0031891839).The manufacturing review confirmed that all devices associated with this batch were the correct size (16 mm x 2.75 mm) per manufacturing records and box labelling.The promus premier select 16 mm x 2.75 mm has a minimum stent length specification of 15.71 mm, and a maximum stent length specification of 17.21 mm.Any stent length that falls outside of these limits is automatically scrapped.All distributed devices from finished goods batch (fgb) 0031891839 passed this inspection and were within the specified stent length limits.From the thorough investigation of all data gathered, it is not possible for a fgb of 16 mm x 2.75 mm devices to include a 20 mm x 4.00 mm sized device.Although the current manufacturing controls confirmed that all devices in batch 0031891839 were correctly measured as 16 mm x 2.75 mm stents, the misprint on the actual hub was not identified during manufacturing.Device analysis: the promus premier select device was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.Printed on the manifold number was the stent size of a 4.00 x 20mm stent, however the actual device measured correctly per the box labelling, which was labelled as a 16mm x 2.75 promus premier select.No other device issues were noted during analysis.Labeling review: based on the available information, there was no evidence of device misuse, off-label use, or failure to follow the promus premier select coronary stent system instructions for use (ifu).Upon medical safety review, it appears the device was used appropriately and as intended in accordance with the ifu.Investigation conclusion: based on a thorough review of the reported event, boston scientific has assigned an investigation conclusion code of 'manufacturing deficiency', since the problem was traced to the manufacturing process.The print size on the hub was a 4.00 x 20mm, however the actual device measured correctly per the box labelling, which was labelled as a 16mm x 2.75 promus premier select.An ncep investigation has been initiated to identify the cause of the incorrect product size etched on the hub manifolds from this batch (0031891839).In addition, boston scientific initiated a medical device removal (97172244-fa) of batch 0031891839 of promus premier select coronary stent systems on 11 march 2024 due to an incorrect product size printed on the catheter manifold hub.

Event Description

It was reported to boston scientific (bsc) that the referenced 16 mm x 2.75 mm promus premier select coronary stent system was selected for use.When unpackaging the device, it was noted that the stent was 20 mm x 4.0 mm.There was no anomaly noted with the packaging prior to use.A replacement device of the correct size was selected to complete the procedure successfully.No patient complications were reported as a result of this event.

• Brand Name: PROMUS PREMIER SELECT
• 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: 18426934
• MDR Text Key: 331795810
• Report Number: 2124215-2023-74711
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10663
• Device Catalogue Number: 10663
• Device Lot Number: 0031891839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 97172244-FA
• Patient Sequence Number: 1