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

Model Number H7493911416350

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Dyspnea (1816); Nausea (1970); Reocclusion (1985); Diaphoresis (2452)

Event Date 10/11/2016

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.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)(4) clinical study.It was reported that chest pain and in-stent restenosis (isr) occurred.In (b)(6) 2013, the patient presented due to angina.Subsequently, coronary angiography and index procedure were performed.The target lesion #1 was a de novo lesion located in the distal left circumflex (lcx) with 90 % stenosis and was 10mm long with a reference vessel diameter of 2.75 m.The lesion #1 was treated with direct placement of a 2.75x12 mm promus element¿ plus drug-eluting stent, with 0% residual stenosis.The target lesion #2 was a de novo lesion located in the proximal lcx with 95% stenosis and was 10mm long with a reference vessel diameter of 3.5mm.The lesion #2 was treated with direct stent placement using a 3.50x16mm promus element¿ plus drug-eluting stent with 0% residual stenosis.Additionally, 90% in-stent restenosis (isr) of unknown stent located in the ramus was treated with angioplasty with 10% residual stenosis.Post deployment of the 3.50x16mm promus element¿ plus study stent in the proximal circumflex, some material of the plaque was shifted in to the ramus which was further treated by balloon angioplasty with a non-compliant balloon with 0% residual stenosis and timi-3 flow.One day post procedure, the patient was discharged on clopidogrel.In (b)(6) 2016, the patient was presented with complaints of exertional chest pain, pressure associated with shortness of breath, diaphoresis and nausea.Subsequently, the patient was hospitalized on the same day and patient was further referred for cardiac catheterization.Coronary angiography revealed a 90% isr of the 3.50x16mm promus element¿ plus study stent located in proximal lcx and was treated with angioplasty with 10% residual stenosis.Additionally, the 90% isr of unknown stent located in ramus was treated with angioplasty with 10% residual stenosis.On the following day, the event was considered as resolved and the patient was discharged on the same day on plavix.

Manufacturer Narrative

Event date: updated and corrected from 10/24/2016 to 10/11/2016.Describe event or problem, relevant tests/lab data, other relevant history updated.(b)(4).

Event Description

It was further reported that in (b)(6) 2016, the patient visited the study hospital and patient was planned for cardiac catheterization.Thirteen days later, the patient returned to hospital for the planned cardiac catheterization.

• 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: 6298916
• MDR Text Key: 66430703
• Report Number: 2134265-2017-00724
• 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,Followup
• Report Date: 01/17/2017

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: 05/20/2013
• Device Model Number: H7493911416350
• Device Catalogue Number: 39114-1635
• Device Lot Number: 15346502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2012
• 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; Required Intervention
• Patient Age: 61 YR