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

Model Number H7493952832300

Device Problem Occlusion Within Device (1423)

Patient Problems Cardiomyopathy (1764); Dyspnea (1816); Reocclusion (1985); Pulmonary Edema (2020); Discomfort (2330); Respiratory Failure (2484)

Event Date 06/18/2015

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)(4).It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2014, the patient's qualifying condition was the admission due to myocardial infarction (mi).The patient underwent an urgent percutaneous coronary intervention (pci).The target lesion was a de novo lesion located in the mid left anterior descending (lad) with 100% stenosis.It was 24 mm long, with a reference vessel diameter of 3.0 mm.Thrombus was present.The thrombolysis in mi was(timi) 0 flow.The target lesion was treated with pre-dilatation of a 2.5mm balloon catheter at 12 atmospheres and placement of a 3.0x32mm promus premier¿ drug eluting stent.Post-dilatation was performed using a 3.5mm balloon catheter at 16 atmospheres.There was 0% residual stenosis.The thrombolysis in mi was (timi) 3 flow.Three days post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient was diagnosed with a life- threatening non st-segment elevation myocardial infarction (nstemi), which required hospitalization.The patient experienced severe shortness of breath and some chest discomfort which began approximately 3 hours prior to admission.The patient was diagnosed with a pulmonary edema due to ischemic cardiomyopathy and respiratory failure, which required intubation.In addition, an electrocardiogram (ecg) revealed a new left bundle branch block and the patient was hypertensive.Subsequently, coronary angiography was performed and revealed a widely patent stent in the proximal portion of lad.The mid-portion of the lad, which had been previously stented with 3.0x32mm promus premier¿ drug eluting stent, had some diffuse isr with approximately 40% narrowing.No revascularization was performed.The patient was treated in the intensive care unit (icu) with mechanical ventilation, diuresis, intravenous nitroglycerin, beta blockers, an ace inhibitor, and a statin.Four days from admission, the patient was extubated.Three days later post procedure, the event was considered resolved and the patient was discharged on aspirin and clopidogrel.

• 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: 5248419
• MDR Text Key: 32088795
• Report Number: 2134265-2015-08290
• 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: 06/29/2015

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 Expiration Date: 02/20/2016
• Device Model Number: H7493952832300
• Device Catalogue Number: 39528-3230
• Device Lot Number: 0017329488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2014
• 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: 54 YR