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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493911416300
Device Problem Occlusion Within Device (1423)
Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Thrombosis (2100); Obstruction/Occlusion (2422); ST Segment Depression (2487)
Event Date 09/17/2016
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 med watch will be filed. (b)(4).
 
Event Description
Same case as mdr id 2134265-2017-00518, 2134265-2017-00519 and 2134265-2017-00520. (b)(6) clinical study. It was reported that stent thrombosis occurred. In (b)(6) 2013, the patient presented with unstable angina and myocardial infarction (mi) and was referred for cardiac catheterization. Subsequently, index procedure was performed. Target lesion #1 was an ostial lesion located in proximal portion of saphenous vein graft (svg) to first obtuse marginal (om) with 99% stenosis and was 20 mm long with a reference vessel diameter of 3. 0 mm. Target lesion #1 was treated with direct stent placement using a 3. 00 mm x 24 mm promus element plus stent, with 0% residual stenosis. Target lesion # 2 was located in mid portion of svg to first om with 70% stenosis and was 15 mm long with a reference vessel diameter of 3. 0 mm. It was treated with direct stent placement using a 3. 00 mm x 16 mm promus element plus stent, with 0% residual stenosis. Two days post procedure, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2015, a promus premier stent was implanted at svg to first om. In (b)(6) 2016, the patient presented with complaints of chest discomfort along the mid sternal area with radiating into the right chest, back and left arm and was admitted in the emergency room (er) on the same day. Upon admission to the er, electrocardiogram (ecg) was taken which revealed st depression in anterior leads and t wave inversion in anterolateral leads. The patient received one dose of sublingual nitroglycerine for her chest pain with a substantial hypotensive episode which required iv saline bolus with improvement of her blood pressure. On the following day, the patient's chest pain was substantially better after the sublingual nitroglycerine treatment but as her blood pressure improved her chest pain returned. Another ecg was taken which revealed st wave depression in leads v5 and v6 and t wave inversion in leads 1 and avl. The cardiac enzymes were noted to be elevated and the patient was diagnosed with non-st-elevation myocardial infarction (nstemi). On the same day, the patient was transferred to the coronary care unit and was referred for cardiac catheterization. The subtotal occlusion with heavy burden in distal body of svg to om1 was successfully treated with balloon angioplasty and percutaneous transluminal coronary angioplasty ptca (thrombectomy). During the ptca there was a small dissection noted at the edge of the distal most stent at the anastomotic site. This dissection was treated with a 2. 0 x 15 mm non-bsc stent placement in the distal most end of the graft into the native vessel. Post procedure there was timi 3 flow restoration. The mid graft was treated with placement of 3. 0 x 24 mm synergy stent. There was an excellent final angiographic result with slow flow. This was treated with intracoronary nitroglycerine. The non-stented segment between the previously placed graft stents (study stent) were found to have ectasia and a possible dissection versus straining across the wire. This segment was treated with 3. 5 x 32 mm drug eluting stent bridging the proximal and the distal graft stents. Post procedure there was an excellent final angiographic result with no residual stenosis, no dissection and timi flow 3. The isr of the proximal study stent was treated with balloon dilation with a 3. 0 noncompliant balloon at 12 to 14 atmospheres in two separate inflations. Post procedure there was an excellent final angiographic results with no residual dissection and timi 3 flow. Three days post procedure, the event was considered as resolved and the patient was discharged on aspirin and clopidogrel.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that in (b)(6) 2016, the patient was diagnosed with non st-segment elevation myocardial infarction.
 
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Brand NamePROMUS ELEMENT¿ PLUS
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6294053
MDR Text Key66274845
Report Number2134265-2017-00571
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/03/2013
Device Model NumberH7493911416300
Device Catalogue Number39114-1630
Device Lot Number15312826
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/01/2017 Patient Sequence Number: 1
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