MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE PROMUS ELEMENT¿ PLUS; STENT, CORONARY, DRUG-ELUTING

Model Number H7493911420300

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Dyspnea (1816); Fatigue (1849); Reocclusion (1985)

Event Date 05/31/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(6) clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2012, index procedure was performed.The target lesion was a de novo lesion located in the mid right coronary artery (rca) with 80% 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 3.00 mm x 20 mm promus element plus stent, with 0 % residual stenosis and timi 3 flow.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented to emergency department with the complaints of shortness of breath with exertion and chest discomfort.The patient was hospitalized on the same day.Due to the patient's multiple comorbidities including exertional dyspnea, chest pain, fatigue, and abnormal stress test, it was decided to medically manage his condition.In (b)(6) 2016, the patient was sent for cardiac catheterization which revealed 50% in-stent restenosis of the promus stent deployed in the mid rca.No intervention was performed and the event was considered to be not resolved.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7341685
• MDR Text Key: 102494935
• Report Number: 2134265-2018-01985
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2018

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: 03/25/2013
• Device Model Number: H7493911420300
• Device Catalogue Number: 39114-2030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2012
• 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
• Patient Age: 60 YR