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

Model Number UNK634

Device Problem Occlusion Within Device (1423)

Patient Problems Intimal Dissection (1333); Aneurysm (1708); Stroke/CVA (1770); Myocardial Infarction (1969); Reocclusion (1985); Perforation of Vessels (2135); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Literature citation: mahmoud sabbah md, et.Al., clinical and angiographic outcomes of axial stent deformations in unrestricted real world patient population, journal of interventional cardiology, 2017:30:550-557.Device is combination product.Age at time of event: 70+/-9 years.If implanted, give date: february 2012-march 2013.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr# 2134265-2018-01031 and 2134265-2018-01497.It was reported via journal article that serious injury occurred.This study evaluated the study evaluated the prevalence, predictors, and the mid-term clinical outcomes of lsd following implantation of promus element des in unrestricted real world coronary lesions.Between february 2012 and march 2013, a total of 3700 lesions were revascularized using different des platforms and/or percutaneous balloon angioplasty.Of these, 961 promus element stents were successfully deployed in 833 lesions (in 494 patients) with no pre-specified inclusion or exclusion criteria.All interventions were performed using standard techniques.Although different second and third generations des were available, technical, procedural, and device selection were left to the operator's discretion.Two independent observers reviewed all procedures, and in-hospital and mid-term clinical, and angiographic outcomes were compared between lesions with and without stent deformation.Patients had multiple coronary risk factors; diabetes mellitus (dm), hypertension (htn), and dyslipidemia.The recurrent anginal pain was the leading indication for interventions (73%) while patients with acute mi accounted for (11%) of the revascularized lesions.The predominant target vessels were the right coronary artery (rca), and left anterior descending (lad) artery.Post procedural timi flow grade 3 was obtained in all patients.Events observed included, death, serious injury (including myocardial infarction, restenosis, stroke, aneurysm, vessel dissection, vessel perforation) and longitudinal stent deformation.

• Brand Name: PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7273666
• MDR Text Key: 100175878
• Report Number: 2134265-2018-00974
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2018

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: UNK634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention