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

Model Number H7493952824270

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); ST Segment Elevation (2059); Thrombosis (2100); Vomiting (2144)

Event Date 01/14/2015

Event Type  Injury  

Event Description

Same case as mdr id#2134265-2015-00584.It was reported that thrombosis, chest pain, st elevation, ekg changes and vomiting occurred.In (b)(6) 2015, patient presented with constant severe chest pain.Upon arrival at the emergency room, patient was noted to have anterior st segment elevation.Code st-elevation myocardial infarction (stemi) was called and patient was brought to the cardiac cath lab.Upon arrival at the cath lab, patient was given aspirin, intravascular (iv) angiomax and 600 mg plavix.An emergent cardiac catheterization was performed.It revealed an ostial 100%, occluded left anterior descending (lad) artery which was full of thrombus.A choice pt floppy guide wire was advanced.Dilatation was performed using a 2.5x12mm unspecified balloon catheter.It was noted that there was a large thrombus burden in the lad and a diffuse disease in the distal lad.However, the culprit lesion was noted to be in the ostial of the proximal lad with a large thrombus burden.Manual aspiration of the thrombus was performed and a large quantity of the thrombus was removed.Multiple balloon dilatation was performed to establish flow in the lad.The patient had moderate calcification, however, after multiple balloon dilations.Some flow was established.The culprit lesion was identified in the proximal ostial lad.The distal lad appeared to be a relatively small-caliber vessel with some diffuse disease.A 2.75 x24mm promus premier¿ stent was then advanced and deployed in the ostium to the proximal lad covering the lesion.Post dilatation was performed using a 2.7 compliant balloon.Normal brisk flow into the lad was noted.Distal lad was relatively small caliber vessel with diffuse disease which was a non-culprit lesion.Brisk normal timi 3 flow was established and interventional procedure was then completed.The physician moved onto the right coronary artery (rca).Angiogram revealed 30 to 40% stenosis in the mid part of the rca.Lv gram was performed in rao projection only which showed anteroapical akinesis, almost mild apical and anterior aneurysm was noted.Ejection fraction was noted to be 30 to 35%.A 1+ mitral regurgitation was also noted.An unspecified sheath was removed.Angio-seal closure device was used to achieve good hemostasis and the procedure was completed.The patient was then sent to the intensive care unit (icu).Four hours post procedure, the patient developed sudden chest pain.A repeat ekg was done which showed st elevation again in the anterolateral lead which was originally resolved after the first procedure.Apparently, the patient had several episodes of vomiting in the icu.Patient was given zofran and phenergan.The patient continued to have dry heaving and multiple episodes of vomiting.In view of new onset of chest pain and abnormal ekg, the patient was emergently sent back to cardiac cath lab.Angiogram was performed and it was noted that the patient developed thrombosis of the stent in the proximal ostial lad.Percutaneous transluminal coronary angioplasty (ptca) was performed and repeat thrombus aspiration was also performed.Multiple balloon dilatation of the stent was performed using a non compliant balloon catheter.The distal lad again appeared to be a small-caliber vessel with a diffuse disease.There was another lesion in the distal lad and haziness was noted distal to the 2.75 x24mm promus premier¿ stent in the lad.A 2.5x12mm unspecified stent was deployed in the hazy area.A 2.0 balloon was used to dilate the diffusely diseased distal lad.Post dilatation of both stents were performed and timi-3 flow was established.Intra aortic balloon pump was inserted and the patient was sent back to the icu.Three days post procedure, the patient was brought to the cath lab as a rapid response/code was called to the floor.It was noted that the patient was in third-degree block with st elevation in ii, iii and augmented vector foot (avf).The patient was given dopamine, atropine, and fluids.Angiography was performed in the left and right coronary system.It was noted then that the patient had a patent lad artery, had 85% middle to distal lad lesion which was noted before but with good timi 3 flow.The circumflex artery had a 50% proximal lesion and the right coronary artery (rca) had 100% lesion in the proximal and clot was noted.There was also a 50% ostial lesion noted.Left ventricularogram was performed and showed ejection fraction approximately 20% with global, inferior and apical hypokinesia.End- diastolic pressure (edp) was elevated at 25mmhg.A 2.25x16mm promus premier¿ stent was advanced and deployed to treat the proximal posterior descending artery (pda).Multiple inflations were performed at the distal pda and manual thrombectomy was also performed.However, full timi 3 flow was not achieved as significant clot burden was noted.The thrombectomy device could barely reach distally in the pda as the vessel was small.Percutaneous transluminal coronary angioplasty (ptca) was done with a 2-0 balloon catheter of the middle to distal lad.It was noted that the 80% stenosed lesion reduced to less than 20% residual.Intra aortic balloon pump was done prior to intervention as the patient was in cardiogenic shock and the blood pressure was low.Dopamine and levophed were given to support the patient's blood pressure.Then, a right heart catheter was inserted for monitoring.The patient's wedge pressure was 14mmhg and pa pressure of 25/10.The patient was given aspirin and plavix and was on iib/iiia inhibitor during the case.Intracoronary nitroglycerin, integrilin and adenosine were also given and the procedure was completed.No further patient complications were reported and the patient was doing well.

Manufacturer Narrative

(b)(4).Device is 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).

• Brand Name: PROMUS PREMIER?
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4487463
• MDR Text Key: 18091915
• Report Number: 2134265-2015-00527
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H7493952824270
• Device Catalogue Number: 39528-2427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 75 YR