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

Model Number 9548

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

Patient Problem Unspecified Infection (1930)

Event Date 08/16/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6).

Event Description

(b)(4) clinical study.It was reported that low grade infection occurred.In (b)(6) 2018 the patient was presented to the hospital due to unstable angina and was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the prox lad extending up to mid lad with 90% stenosis and was 12 mm long, with a reference vessel diameter of 4.0 mm.The target lesion was treated with pre-dilatation and placement of a 4.0 mm x 12 mm promus priemiere stent.Post dilatation was performed with 0% residual stenosis.The patient was discharged on aspirin and clopidogrel.One day post index procedure, the patient was diagnosed with low-grade infection.Medication was given to treat the event.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: 7959797
• MDR Text Key: 123493551
• Report Number: 2134265-2018-61783
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2019
• Device Model Number: 9548
• Device Catalogue Number: 9548
• Device Lot Number: 0021418983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2017
• 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