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

Model Number 10662

Device Problems Break (1069); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/15/2024

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter phone: (b)(6).

Event Description

It was reported that a shaft break occurred, resulting in un-retrieved device fragment.A 12 x 4.00mm promus premier select stent balloon expandable was selected for treatment.During the procedure, a fracture was noted resulting in an unretrieved device fragment.The patient was admitted to hospital beyond the standard of care.No further information is available.

Manufacturer Narrative

B5: describe event or problem: updated.H6: device codes: updated.E1: initial reporter phone: (b)(6).

Event Description

It was reported that a shaft break occurred, resulting in unretrieved device fragment.A 12 x 4.00mm promus premier select stent balloon expandable was selected for treatment.During the procedure, a fracture was noted resulting in an unretrieved device fragment.The patient was admitted to hospital beyond the standard of care.No further information is available.It was further reported that target lesion was very tortuous.Stent was deployed partially, and procedure was completed successfully.Patient was discharged from the hospital.

• 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: 19073075
• MDR Text Key: 339736591
• Report Number: 2124215-2024-20885
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10662
• Device Catalogue Number: 10662
• Device Lot Number: 0031125744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• 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
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 7 MO