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

Model Number UNK758

Device Problem Occlusion Within Device (1423)

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Dyspnea (1816); Ischemia (1942); Reocclusion (1985); Pleural Effusion (2010)

Event Date 02/11/2015

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: 2134265-2016-03107 and mdr id: 2134265-2016-03106.(b)(6) clinical study.It was reported that in stent restenosis (isr) occurred.In (b)(6) 2013, the patient was noted to have symptoms of shortness of breath on exertion with stress echocardiogram positive for stress-induced ischemia.Subsequently, coronary angiography and index procedure were performed.The target lesion was a de novo lesion located in the mid right coronary artery (rca) with 80% stenosis and was 28mm long with a reference vessel diameter of 3.5mm.The lesion was treated with pre-dilatation and placement of a 3.50x28mm promus element plus stent.Following post-dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient had a 3.5 x 20mm stent implanted in the mid rca and a 3.5 x 8mm stent implanted in the distal rca.In (b)(6) 2015, the patient presented with complaints of chest discomfort consistent with myocardial ischemia and was referred for coronary angiography on the same day.Coronary angiography revealed chronic total occlusion of rca with previously placed study stent mid rca, promus premier stents in mid rca and distal rca respectively.Considering there was difficulty to treat the rca through percutaneous coronary intervention (pci), the patient was referred for a single vessel coronary artery bypass graft (cabg).Fifteen days after the onset of symptoms, the patient underwent single vessel cabg of mid rca using right internal mammary artery (rima) to posterior descending artery (pda).Repeat coronary angiography of the rima to pda graft revealed considerable distal narrowing of 95%.Subsequently, the patient was taken back to the cath lab for revision of the bypass graft.Post revision of the bypass graft, the patient was found to be stable.Two days post bypass surgery, the patient was seen with increased dyspnea and was diagnosed with pneumonia during the course of hospitalization.The patient was treated with antibiotics.Over the next few days, the patient had a persistent right effusion and ultimately due to the cough, the patient was subsequently diagnosed with sternal dehiscence.In response, the patient underwent surgical repair of sternal dehiscence.In (b)(6) 2015, the event was considered resolved.Eight days after, the events of coronary artery disease and post operative pneumonia was considered resolved and the patient was discharged on aspirin and prasugrel.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2015, the patient presented with symptoms of progressive angina and not chest discomfort consistent with myocardial ischemia as previously reported.In (b)(6) 2015, three days post-operative, the patient demonstrated pulmonary edema and a right ct-guided pleural tube was placed which drained bloody fluid.Finally, the patient was diagnosed with pneumonia during the course of hospitalization.Pulmonary and critical care medicine was consulted at that time for help with respiratory insufficiency.The patient then began to have rapid atrial fibrillation and was started on amiodarone and diltiazem.Six days post-operative, the patient went though ct thorax for further evaluation of the right effusion.The results revealed loculated pleural thickening and positive air bronchogram.The patient was treated with antibiotics.Eight days post-operative, cardiac consultation was done for the persistent atrial fibrillating and the patient was started on coumadin.In (b)(6) 2015, the post-operative atrial fibrillation was considered resolved.

• Brand Name: PROMUS PREMIER¿
• 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: 5591031
• MDR Text Key: 43101061
• Report Number: 2134265-2016-03108
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR