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

Model Number H7493911420350

Device Problem Occlusion Within Device (1423)

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Reocclusion (1985)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product. Complainant address: (b)(6). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

Event Description

(b)(6) clinical study. It was reported that myocardial infarction and in-stent restenosis occurred. In (b)(6) 2013, clinical status assessment identified the patient's qualifying condition as ischemia and stable angina. Subsequently, coronary angiography and index procedure were performed. The target lesion was located in the mid left anterior descending (lad) with 90% stenosis, a length of 16 mm and a reference vessel diameter of 3. 5 mm. The lesion was treated with pre-dilatation and placement of a 3. 50 x 20 mm study stent. Following post-dilatation, residual stenosis was 0%. One day post procedure, the patient was discharged on dual antiplatelet therapy. In (b)(6) 2016, the patient developed chest pain radiating to the left arm and neck. In addition, the patient also had dyspneic symptoms and orthopnea. The following day, patient was presented to non study hospital with complaints of chest pain which got resolved early in the morning and dyspnea on exertion. Patient was hospitalized for the same. An electrocardiogram (ecg) was performed, which revealed atrial fibrillation with complete right bundle branch block. Chest x-ray was performed, which revealed an enlarged heart. Echocardiogram revealed a greatly reduced ejection fraction (ef) and mitral insufficiency. On the same day, cardiac enzymes were noted to be elevated (peak troponin: 0. 0415 ng/ml, uln: 0. 014 ng/ml). Site has reported an event of myocardial infarction (mi). Patient was treated with medication in response to the event. Six days from the onset of symptoms, an electric reconversion was performed to treat the persistent atrial fibrillation. Subsequently, coronary angiography and transesophageal echocardiography (tee) were planned to be performed in (b)(6) 2017. In (b)(6) 2017, the subject was discharged on acetyl salicylic acid. Six days later, the patient came to study hospital for the planned coronary angiography and ecg was performed, which revealed first grade av block, right bundle branch block. On the next day, coronary angiography revealed that lad had less than 30% proximal in stent restenosis including the first diagonal at the level of implanted study stent. Subsequently, tee was performed, which revealed slightly dilated left ventricle with significantly decreased systolic function. In addition, thorax x-ray was also performed which revealed substantially widened heart. Patient's medication regimen was adjusted in response to the event. It was decided to reevaluate the patient within 6 weeks at the ambulatory care. The following day, the patient was discharged to home.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6336235
• MDR Text Key: 67595587
• Report Number: 2134265-2017-01157
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/13/2013
• Device Model Number: H7493911420350
• Device Catalogue Number: 39114-2035
• Device Lot Number: 15612811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/16/2017 Patient Sequence Number: 1