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

Model Number 9549

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

Patient Problem Unspecified Infection (1930)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: (b)(6).Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that pulmonary infection occurred.In (b)(6) 2018, the patient was referred for cardiac catheterization.Subsequently, the procedure was performed on the same day.The target lesion #1 was located in the proximal left anterior descending artery (lad) to distal lad with 90% stenosis and was 16 mm long, with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of a 16 x 3.00mm promus premier drug-eluting stent.Following post dilatation,the residual stenosis was 0%.On the same day of he index procedure the patient was noted with pulmonary infection which was treated medically.On unknown date, the patient was discharged on aspirin medication.In (b)(6) 2018, the event outcome was considered to be 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8907190
• MDR Text Key: 154762825
• Report Number: 2134265-2019-09839
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2019
• Device Model Number: 9549
• Device Catalogue Number: 9549
• Device Lot Number: 0020520635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2017
• 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): Hospitalization; Other