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

Model Number 9550

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/11/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: the 2nd affiliated hospital of (b)(6).

Event Description

(b)(6).It was reported that the patient experienced low-grade infection.In (b)(6) 2018, the patient presented with unstable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion as locate in the mid right coronary artery (rca) extending up to distal rca with 95% stenosis and was 20mm long, with a reference vessel diameter of 4mm.The target lesion was treated with pre-dilatation and placement of 4 mm x 20 mm promus premiere stent.Post dilatation was performed with 0% residual stenosis.One day post index procedure, the patient experienced low-grade infection.No action was taken to treat the event.At the time of reporting, the event was considered not recovered/ not resolved.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7904038
• MDR Text Key: 121558545
• Report Number: 2134265-2018-61023
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/24/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2019
• Device Model Number: 9550
• Device Catalogue Number: 9550
• Device Lot Number: 0021340898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• 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): Required Intervention
• Patient Age: 55 YR