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

Model Number 10664

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3: as the event date was not reported, the first day in the month of the aware date is provided.E1: initial reporter telephone (b)(6).

Event Description

It was reported that a stent fracture occurred.A 20 x 4.00 promus elite drug-eluting stent was selected for treatment.However, during opening of the package the promus elite stent was noted to be kinked and fractured into two pieces.There were no issues noted with the device packaging and no difficulties were encountered when removing the promus elite from the packaging.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

Event Description

It was reported that a stent fracture occurred.A 20 x 4.00 promus elite drug-eluting stent was advanced for treatment.However, during opening of the package the promus elite stent was noted to be kinked and fractured into two pieces.There were no issues noted with the device packaging and no difficulties were encountered when removing the promus elite from the packaging.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.It was further reported the stent was broken into two pieces in the middle of the metal struts.

Manufacturer Narrative

Correction to b5: previously it was reported a 20 x 4.00 promus elite drug-eluting stent was advanced for treatment.Corrected to a 20 x 3.00 promus premier select drug-eluting stent was selected for use.B3: as the event date was not reported, the first day in the month of the aware date is provided e1: initial reporter telephone: (b)(6).

Event Description

It was reported that a stent fracture occurred.A 20 x 3.00 promus premier select drug-eluting stent was selected for treatment.However, during opening of the package the promus elite stent was noted to be kinked and fractured into two pieces.There were no issues noted with the device packaging and no difficulties were encountered when removing the promus elite from the packaging.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.It was further reported the stent was broken into two pieces in the middle of the metal struts.

Manufacturer Narrative

Correction to b5: previously it was reported a 20 x 4.00 promus elite drug-eluting stent was advanced for treatment.Corrected to a 20 x 3.00 promus premier select drug-eluting stent was selected for use.B3: as the event date was not reported, the first day in the month of the aware date is provided e1: initial reporter telephone: (b)(6).Device evaluated by manufacturer: the promus premier select ous mr 20 x 4.00mm stent delivery system (sds) was returned for investigation.Visual, tactile, microscopic analysis, and dimensional testing were performed on the device.Examination found evidence of tip damage and stent struts lifted and pulled distally from the proximal section.No other device issues were identified during returned product analysis.The reported fracture was no confirmed.Based on the results of the device analysis, this event does not meet the criteria for a reportable event.The reported event of stent fracture was unable to be confirmed.Upon analysis, stent damage was confirmed, however this does not meet the criteria of a reportable event.Damage to a stent or stent strut would not cause or contribute to vessel trauma or other complication which may cause or contribute to a death or serious injury or result in additional medical/surgical intervention required to prevent a serious injury.

• 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: 18195498
• MDR Text Key: 328974083
• Report Number: 2124215-2023-66100
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10664
• Device Catalogue Number: 10664
• Device Lot Number: 0031634166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/04/2023; 01/24/2024
• Supplement Dates FDA Received: 12/20/2023; 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• 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