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

Model Number 9586

Device Problem Obstruction of Flow (2423)

Patient Problems Stroke/CVA (1770); Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Anxiety (2328); Numbness (2415)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Estimated based on the aware date of (b)(6) 2019.Estimated based on provided implant date of (b)(6) 2016.Device is a combination product.

Event Description

It was reported that stent restenosis occurred.As reported by the patient, a 24mm x 2.5mm promus premier stent was implanted in (b)(6) 2016.Since that time, the patient has not felt right.The patient experienced an increase in blood pressure despite medication and intense chest pain.The patient has also experienced eight strokes and twelve new heart attacks which has led to right-sided numbness, difficulty walking and anxiety.Per report, the implanted stent is now occluded and remains implanted in the patient with no further intervention.

• 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: 8896523
• MDR Text Key: 154406991
• Report Number: 2134265-2019-09728
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9586
• Device Catalogue Number: 9586
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Life Threatening