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

Model Number H7493911612300

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Reocclusion (1985); Chest Tightness/Pressure (2463)

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-12494.(b)(6).It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2012, the patient was presented with a single episode of chest discomfort and strong family history of coronary artery disease.Coronary angiography and index procedure were then performed.The target lesion was a de novo lesion located in the proximal left circumflex(lcx) with 60% stenosis and was 8mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with direct placement of 3.00x12mm promus element¿ plus stent resulting in 0% residual stenosis.Target lesion #2 was a de novo lesion located in the mid-distal lcx with 90% stenosis and was 8mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with direct placement of a 3.00x8mm promus element¿ plus stent resulting in 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient was presented to the emergency room with unstable angina and 2 day history of intermittent chest pain.The patient developed anterior chest wall "tightness" with no radiation of symptoms and had taken nitroglycerine in response to that, which relieved his symptoms.On the same day, the patient was admitted to the hospital.Patient's troponin cardiac enzyme to be negative, which continued to trend and patient was ruled out for acute coronary syndrome.Coronary angiography was performed and revealed 80-90% proximal isr and 80% mid vessel isr of previously placed 3.00x12mm and 3.00x8mm promus element¿ plus stents.Six days from admission, the 80-90% proximal isr and 80% mid vessel isr of previously placed study stents were treated with reverse saphenous graft to terminal circumflex.On the same day, the 80% stenosis in mid right coronary artery (rca) and 70% stenosis in mid left anterior descending (lad) were treated by reverse saphenous vein graft to rca and left internal mammary artery to mid distal portion of the lad respectively.Five days post procedure, the patient was seen and evaluated by a cardiologist and the event was considered to be resolved.The patient was then discharged on aspirin and clopidogrel.

• 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: 7124846
• MDR Text Key: 95178750
• Report Number: 2134265-2017-12493
• 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: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2013
• Device Model Number: H7493911612300
• Device Catalogue Number: 39116-1230
• Device Lot Number: 15520507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2012
• 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: 28 YR