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

Model Number H7493911320220

Device Problem Occlusion Within Device (1423)

Patient Problems Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Reocclusion (1985); Chest Tightness/Pressure (2463)

Event Date 12/29/2014

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id# 2134265-2015-05560, 2134265-2015-05557, 2134265-2015-05554, 2134265-2015-05553.Pe-prove clinical study it was reported that stent thrombosis and myocardial infarction occurred.In (b)(6) 2010, the patient was referred for cardiac catheterization which revealed the 90% stenosed, de novo target lesion located in the 1st left posterolateral branch segment (lpl) of the left coronary artery that was 12mm long with a reference vessel diameter of 2.25mm.The target lesion was treated with predilatation and placement of a 2.25 x 20mm promus element stent resulting to 0% residual stenosis.One day post index procedure, the patient was discharged on aspirin and prasugrel.In (b)(6) 2014, the patient's cardiac enzymes were found to be elevated and the site reported an event of myocardial infarction (mi).The patient was subsequently hospitalized on the same day.Ecg was performed and the patient was referred for coronary angiography which revealed 50-75% in-stent restenosis in the small postero-lateral branch, in-stent restenosis in the mid segment of the right coronary artery (rca) and 75% stent thrombosis with complete occlusion of the promus element stents in the distal rca which were implanted in (b)(6) 2010.On the same day, stent thrombosis of the previously implanted promus element stents were treated with thrombus aspiration and implantation of a 2.25 x 11mm non-bsc stent at the origin of the right posterior descending segment of rca, a 2.50 x 24mm stent in the right lpl branch and a 3.50 x 18mm stent in the mid rca.The event was then considered resolved without residual effects.(b)(6) post procedure, the patient was discharged.

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id# 2134265-2015-05560, 2134265-2015-05557, 2134265-2015-05554, 2134265-2015-05553.It was further reported that in (b)(6) 2014, the patient experienced sudden tightness in the chest with no radiation or dyspnea.The patient contacted the emergency doctor immediately and was subsequently hospitalized.Ecg revealed st elevation.The patient was discharged on aspirin and prasugrel.

• Brand Name: PROMUS ELEMENT ¿
• 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: 5018042
• MDR Text Key: 23560853
• Report Number: 2134265-2015-05559
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2011
• Device Model Number: H7493911320220
• Device Catalogue Number: 39113-2022
• Device Lot Number: 13487062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2010
• 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: 57 YR