MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Catalog Number UNKNOWN

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

Patient Problem Atrial Fibrillation (1729)

Event Type  Injury  

Manufacturer Narrative

The adverse events reported in the literature for the cdt group with ekos were attributed to the tpa and the procedure.The new onset of renal failure is likely attributed to the contrast media associated with the procedure.The author attributed the atrial fibrillation to the procedure.No device malfunctions were reported.It should be noted that pe is a risk factor for atrial fibrillation and cardiac arrhythmias are listed as a potential complication in the instructions for use.No patient or device specific information was available for the 11 submassive pe patients treated with ekos between oct 1999 and may 2015 that experienced atrial fibrillation.No additional information is expected.

Event Description

The following publication was reviewed as a part of post-market surveillance and reported safety outcomes: title: surgical pulmonary embolectomy and catheter-directed thrombolysis for treatment of submassive pulmonary embolism authors: ahmed a.Kolkailah md, sameer hirji md, gregory piazza md, ms, julius i.Ejiofor md, mph, fernando ramirez del val md, mph, jiyae lee bs, siobhan mcgurk bs, sary f.Aranki md, prem s.Shekar md, tsuyoshi kaneko md facility: harvard medical school, boston, massachusetts.A review of 133 submassive pe patients between oct 1999 and may 2015 that underwent treatment with pulmonary embolectomy (71) or cdt with ekos (62).Operative or procedural mortality was 5.3% for the entire cohort, and statistically similar between the two groups (ie, 7.0% in the pulmonary embolectomy group and 3.1% in the cdt group, p = 0.448).The primary cause of death among patients undergoing pulmonary embolectomy was progressive rv failure (100%), while one patient died of massive hemothorax due to respiratory failure in the cdt group.Bleeding complications occurred in both groups, although significantly higher among patients in the cdt group (9.7%) compared to the pulmonary embolectomy cohort (1.4%, p = 0.025).Of the six cases (9.7%) with bleeding complications in the cdt group, one patient had received systemic thrombolysis 2 days before the ekos procedure and had bleeding at the right internal jugular site, while two patients had minor groin and incisional (c-section) hematomas, respectively.One patient developed hemoptysis; another patient developed frank melena due to a gastrointestinal malignancy with liver metastasis, requiring initiation of chemotherapy; and one patient had a ventriculo-peritoneal shunt and developed intracranial hemorrhage, with no focal neurological deficits, after starting heparin.One patient (1.4%) in the pulmonary embolectomy group developed melena, this patient received systemic thrombolysis before arriving at our institution.Patients in the cdt group had significantly lower rates of new onset renal insufficiency (1.6% vs 12.7%) and atrial fibrillation (17.7% vs 18.3%, all p < 0.05).Postoperative complications reported for the cdt group with ekos: death (massive hemothorax due to respiratory failure) (1), atrial fibrillation (11), new onset of renal failure (1), bleeding complications (6), ich (1), recurrent (in-house) pe (1).Follow up information was received from the corresponding author with the relatedness of the cdt group events: one death (massive hemothorax due to respiratory failure) - tpa related, eleven (11) occurrences of atrial fibrillation- procedure related, one new onset of renal failure - procedure related, six (6) bleeding complications - tpa related, one ich - tpa related, one recurrent (in-house) pe - tpa related.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer Contact: sandra bausback ; 300 four falls corp. center; 300 conshohocken st rd, # 300; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 7863772
• MDR Text Key: 119794650
• Report Number: 3001627457-2018-00027
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140151
• 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: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention