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

Model Number H7493911412300

Device Problem Occlusion Within Device (1423)

Patient Problems Myocardial Infarction (1969); Nausea (1970); Reocclusion (1985); Dizziness (2194); Discomfort (2330); Sweating (2444)

Event Date 01/17/2016

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 myocardial infarction (mi) and in-stent restenosis (isr) occurred.In (b)(6) 2013, the patient presented due to stable angina and was referred for cardiac catheterization.Target lesion # 1 was a de novo lesion located in proximal left anterior descending (lad) artery with 80% stenosis and was 8.0mm long with a reference vessel diameter of 3.00mm.Target lesion # 1 was treated with direct placement using a 3.00x12mm promus element plus drug-eluting stent, with 0% residual stenosis.The following day, the patient was discharged on aspirin.In (b)(6) 2016, the patient presented emergently due to nausea, sweating, dizziness and chest discomfort.Electrocardiogram (ecg) was performed which revealed st elevation in v1-3 and normal sinus rhythm.Cardiac enzymes levels were noted to be elevated and the site reported an event of non q wave mi and the patient was referred for left cardiac catheterization.The 60-80% stenosis located in proximal to mid lad was treated with direct stent placement using a 3.00mm x 26.00mm non-bsc stent, with 0% residual stenosis.Additionally, balloon angioplasty was performed in ostium of 1st diagonal branch, with excellent results.On the same day, the mi was considered resolved.Two days later, the patient was discharged on aspirin.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5438385
• MDR Text Key: 38247284
• Report Number: 2134265-2016-00548
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2014
• Device Model Number: H7493911412300
• Device Catalogue Number: 39114-1230
• Device Lot Number: 15879862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2013
• 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: 52 YR