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

Model Number UNK717

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Myocardial Infarction (1969); ST Segment Elevation (2059); Rupture (2208); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Literature citation: yoshizaki, toru et al."a case of ventricular septal rupture associated with major septal branch occlusion after percutaneous coronary intervention".Journal of cardiology cases, 10 (2014) 140-143.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

Reported via journal article.The patient presented with syncope suspected to be due to myocardial ischemia.Percutaneous coronary intervention (pci) of the left anterior descending artery (lad) was performed.The lad was predilated using a 3.0 mm semi-compliant non-bsc balloon catheter.After dilation, an lad dissection occurred.A 3.0 x 32mm promus element plus was deployed in the mid- lad lesion and was post dilated using a 3.0mm non-compliant balloon at 26 atm.Following dilation, the major septal branch became occluded.Ecg revealed an st segment elevation.The patient developed chest pain that resolved with intravenous administration of buprenorphine.The proximal lad was stented using a 3.0x22mm promus element plus, careful not to re-jail the occluded septal branch.After pci, the patient had no symptoms, however the ecg revealed persistent st elevation and a change in the complete right bundle branch block.The patient was discharged 3 days later, with no chest pain.Nineteen days after the pci procedure, the patient returned with dyspnea.Transthoracic echocardiography revealed basal ventricular septal rupture.Emergency coronary angiography was performed which revealed no in-stent restenosis.The major septal branch remained occluded.Intra-aortic balloon pump support was initiated and a cardiac surgeon consulted.The patient underwent closure of the ventricular septal rupture using a double patch and coronary artery bypass graft to the rca.Intraoperative findings revealed that the rupture site was within the basal ventricular septum.The patient's hemodynamic status was stable.The post operative period was uneventful and the patient was discharged 29 days later.The patient is doing well without any recurrence of syncope.

• Brand Name: PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM 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: 5147714
• MDR Text Key: 28135641
• Report Number: 2134265-2015-06903
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• 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
• Patient Age: 67 YR