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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC - GALWAY TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number UNK432
Device Problem Occlusion Within Device (1423)
Patient Problems Angina (1710); Dyspnea (1816); Edema (1820); Fatigue (1849); Reocclusion (1985)
Event Date 03/28/2017
Event Type  Injury  
Manufacturer Narrative
If implanted, give date: (b)(6) 2004. Device is a combination product. Device evaluated by mfr. : the device was not returned for analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. 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 2134265-2017-04802. (b)(6) clinical study. It was reported that angina and in-stent restenosis (isr) occurred. In (b)(6) 2016, clinical status assessment indicated that the patient's qualifying condition as stable angina and the index procedure was performed. Target lesion #1 was an isr of a previously placed taxus stent and an unknown stent located in the 1st diagonal branch with 80% stenosis and was 6mm long with a reference vessel diameter of 2. 5mm. Target lesion #1 was treated with direct placement of a 2. 50 x 12 mm synergy study stent and residual stenosis was 0%. Target lesion #2 was located in the distal left anterior descending (lad) artery with 80% stenosis and was 6mm long with a reference vessel diameter of 2. 25mm. Target lesion #2 was treated with direct placement of a 2. 25 x 12mm synergy study stent and residual stenosis was 0%. On the same day, the patient was discharged on dual antiplatelet therapy (aspirin and clopidogrel). In (b)(6) 2017, patient was seen by the physician with complaints of chest pain with exertion. The patient also had ankle edema and fatigue. The patient was referred for further ischemic evaluation and positron emission tomography (pet) nuclear stress test was scheduled. The patient was advised to continue aspirin, plavix and beta blockers. Six days later, the patient had telephoned in and reported having recurrent chest pressure on exertion with dyspnea consistent with previous angina. The scheduled pet nuclear stress test was cancelled and the patient was referred for cardiac catheterization for further evaluation. Norvasc was added to the patient's regimen. Three days later, electrocardiogram (ecg) was performed which revealed av paced rhythm, left axis deviation, left bundle branch block, possible inferior and later infract. Six days later, coronary angiography was performed and the patient was referred for re-stent percutaneous transluminal coronary angiography to 1st diagonal artery via sv graft. Eight days later, the 90% isr in the 1st diagonal artery was treated with pre-dilatation and placement of a 2. 5 x 8mm synergy stent. Following post-dilatation, residual stenosis was mild and distal flow was timi-3. The patient was advised to continue aspirin, plavix, beta blockers and nitrates, and was discharged on the same day.
 
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Brand NameTAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6557490
MDR Text Key74839228
Report Number2134265-2017-04803
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK432
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 Received04/25/2017
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 Treatment Data
Date Received: 05/10/2017 Patient Sequence Number: 1
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