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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493952824400
Device Problem Occlusion Within Device (1423)
Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Reocclusion (1985); Discomfort (2330)
Event Date 12/18/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 medwatch will be filed. (b)(4).

 
Event Description

(b)(6) study. It was reported that in-stent restenosis (isr) and myocardial infarction (mi) occurred. In (b)(6) 2015, clinical assessment recorded the patient's qualifying condition was unstable angina and mi, and underwent an urgent/emergent percutaneous coronary intervention (pci). The target lesion was a de novo, ostial, bifurcated lesion located in the left main coronary artery (lmca) with 90% stenosis. The left main stenosis involved the left circumflex (lcx), with the most distal site recorded as the proximal cx. The lesion was located within or distal to a >60 degree bend in the vessel. The lesion was 20 mm long and had a reference vessel diameter of 4. 0 mm. There was mild calcification and moderate vessel tortuousity. The target lesion was treated with pre-dilatation with a 2. 5 mm balloon at 14 atmospheres prior to insertion of a 4. 00x24mm promus premier¿ drug-eluting stent. This stent extended into the lcx. There was 0% residual stenosis. Post dilation was performed with a 5. 0mm balloon at 24 atmospheres. No patient complications were noted. The following day, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2015, the patient presented with non-st elevation myocardial infarction (nstemi) with isr of a previously implanted 4. 0x12mm non-bsc stent. The patient also presented with a 2-week history of feeling poorly, and a 2-day history of substantially worsening discomfort, worsening shortness of breath, and increased dyspnea on exertion. The patient received sublingual nitroglycerin, which did not provide significant relief of symptoms, and was started on a nitroglycerin drip at 10 mcgs with relief of pain; additional treatment included heparin and aspirin. The patient was then admitted with the diagnosis of nstemi for evaluation and management. The location of the mi was within the lateral. On the same day, the patient underwent pci for target vessel revascularization (tvr) of the target lesion in the proximal circumflex artery as treatment for angina, elevated cardiac enzymes, and new electrocardiogram (ecg) changes. There was successful balloon angioplasty and stenting of the lm into the lcx with a 3. 5x15mm and a 3. 5x12mm non-bsc drug-eluting stents that were post-dilated. There was no significant residual stenosis and timi flow 3 was established at the end of the procedure. Post pci, the patient reported being pain-free. The following day, the nstemi with isr and tvr were considered resolved and the patient was discharged in stable condition.

 
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Brand NamePROMUS PREMIER¿
Type of DeviceSTENT, 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 Key5381091
MDR Text Key36441004
Report Number2134265-2015-09522
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP110010
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 12/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/20/2016
Device MODEL NumberH7493952824400
Device Catalogue Number39528-2440
Device LOT Number17490794
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 Received12/23/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/11/2014
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: 01/20/2016 Patient Sequence Number: 1
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