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

Model Number UNK758

Device Problem Occlusion Within Device (1423)

Patient Problems Apnea (1720); Chest Pain (1776); Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Myocardial Infarction (1969); Tachycardia (2095); Thrombosis (2100)

Event Date 05/02/2015

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint 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: 2134265-2016-03475.(b)(6) clinical study.It was reported that myocardial infarction (mi) and stent thrombosis occurred and the patient died.In (b)(6) 2013, the patient presented due to unstable angina and was referred for cardiac catheterization.The following day, coronary angiography and index procedure were performed.Target lesion #1 was de novo lesion located in right posterior descending artery(r-pda) with 99% stenosis and was 8mm long with a reference vessel diameter of 2.25mm.Target lesion #1 was treated with pre-dilatation and placement of 2.25x12mm promus element plus drug-eluting stent, with 0% residual stenosis.Target lesion #2 was de novo lesion located in distal right coronary artery (rca) with 80% stenosis and was 14mm long with a reference vessel diameter of 3.0mm.Target lesion #2 was treated with direct stent placement using a 3.00x16mm promus element plus drug-eluting stent with 0% residual stenosis.Target lesion #3 was de novo lesion located in proximal rca extending to mid rca with 85% stenosis and was 13mm long with a reference vessel diameter of 3.0mm.Target lesion #3 was treated with direct stent placement using a 3.00x38mm promus element plus drug-eluting stent.Following post dilatation residual stenosis was 0%.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, two 2.5x16.00mm promus premier drug-eluting stents were implanted in mid left anterior descending artery (lad).In (b)(6) 2015, the patient was hospitalized for worsening congestive heart failure (chf).No action was taken to treat the event.Three days after, the event was considered resolved and the patient was discharged on the same day.In (b)(6) 2015, the patient presented to the emergency department with the chief complaint of shortness of breath and eventually after few hours the patient developed left sided chest pain.The patient was diagnosed with respiratory failure and was intubated.The patient also had sleep apnea for which the patient was sedated.Subsequently, the patient was diagnosed with non-st elevation myocardial infarction (nstemi) and was further referred for emergent cardiac catheterization.The following day, the 100% in-stent restenosis (isr) and stent thrombosis of previously placed two 2.5x16.00mm promus premier drug-eluting stents in lad was treated with thrombectomy and balloon angioplasty.Also intra aortic balloon pump (iabp) was attempted to be placed, as the patient developed bleeding at iabp site, iabp was removed and the patient was placed on protamine.The patient also had acute exacerbation of chf, renal insufficiency and acute hyperglycemia.Two days after, the patient continued to remain on ventilator with severe ischemic cardiomyopathy and with the history of recurrent agitation on attempting to lower intravenous (iv) sedation.Multiple attempts of weaning were failed.Following discussions with patient's family, the patient was extubated and was switched to comfort care.In (b)(6) 2015, six days after being extubated, the patient died.The cause of death was heart failure.

• 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: 5607587
• MDR Text Key: 43618835
• Report Number: 2134265-2016-03474
• 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
• Report Date: 04/06/2016

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: 04/06/2016
• Initial Date FDA Received: 04/26/2016
• 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): Death
• Patient Age: 82 YR