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

Model Number 9549

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that stent dislodgement occurred.After a guidewire crossed the lesion, a 16 x 3.50 promus premier drug eluting stent was selected for use.However, during preparation, the stent came off the balloon as it was being moved along the wire.The stent and balloon were taken off the wire and the procedure was completed with another of the same device.There were no complications reported and the patient was fine.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10626787
• MDR Text Key: 209795057
• Report Number: 2134265-2020-13009
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2020

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 Expiration Date: 03/03/2022
• Device Model Number: 9549
• Device Catalogue Number: 9549
• Device Lot Number: 0025375083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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