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

Model Number UNK340

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Occlusion (1984); Numbness (2415)

Event Date 12/18/2015

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

Event Description

Same case as mdr id 2134265-2016-01333 and 2134265-2016-01337.Platinum diversity clinical study.It was reported that myocardial infarction (mi) and stent occlusion occurred.In (b)(6) 2015, the patient underwent an urgent percutaneous coronary intervention.Target lesion #1 was a de novo lesion located in the distal right coronary artery (rca) with 99% stenosis.It was 20mm long, with a reference vessel diameter of 2.5mm.The lesion was located within or distal to a >60 degree bend in the vessel.The thrombolysis in mi (timi) flow was unknown.Target lesion #1 was treated with pre-dilatation of a 2.0mm balloon at 12 atmospheres and insertion of a 2.25x32 mm promus premier everolimus-eluting platinum chromium coronary stent.Post dilatation was performed with a 2.5mm balloon at 20 atmospheres.Post procedural residual stenosis was 0%.The thrombolysis in mi (timi) flow was 3.Target lesion #2 was treated with pre-dilatation of a 2.0mm balloon at 12 atmospheres and insertion a 2.50x16mm promus premier everolimus-eluting platinum chromium coronary stent.Post dilatation was performed with a 2.5mm balloon at 20 atmospheres.Post procedural residual stenosis was 0%.The thrombolysis in mi (timi) flow was 3.A percutaneous transluminal coronary angioplasty (ptca) of the posterior ventricular branch was performed through the previously placed stent in the distal rca.Due to vessel tortuosity, the physician was unable to advance the non bsc suture-mediated closure system to achieve right common femoral artery hemostasis.Therefore, the sheath was manually pulled post resolution of anticoagulation.Two days later, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient experienced an inferior/posterior mi.The patient presented with a 2-hour history of substernal chest pain, radiating to the jaw and bilateral hands, and associated with numbness in the fingers and shortness of breath.Per the paramedic, the pre-hospital electrocardiogram (ecg) did not show a st elevation myocardial infarction (stemi).The patient was taken directly to the cardiac catheterization lab.The patient underwent ptca with a 2.5x12mm non bsc balloon, followed by insertion of a 2.75x8mm non bsc drug eluting stent to the totally occluded proximal circumflex (cx) with no complications.Fever, due to possible early pneumonia, was treated with omnicef (cefotaxime) and doxycycline.There were no further symptoms.Four days later, the event was considered resolved and the patient was discharged on aspirin and plavix (clopidogrel).

• Brand Name: PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• 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: 5519755
• MDR Text Key: 40962636
• Report Number: 2134265-2016-02168
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• 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: 54 YR