MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM; VENA CAVA FILTER

Catalog Number UNKNOWN G2

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Atrial Fibrillation (1729); Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Thrombosis (2100); Ventricular Tachycardia (2132); Obstruction/Occlusion (2422)

Event Date 08/20/2011

Event Type  Death  

Manufacturer Narrative

No medical images have been made available to the manufacturer.Medical records received and reviewed.Based on the medical records received: patient had a history of coronary artery disease; sometime in 2000, the patient had two coronary artery stents deployed in the heart (lad and circumflex artery).Sometime in (b)(6) 2011, the patient presented with chest pain, chest tightness and shortness of breath.A cardiac cath procedure was performed that demonstrated a 99% occlusion in the lad (left main coronary artery) and 100% stenosis in the pulmonary valve heart with retrograde filling.On (b)(6) 2011 open heart surgery was performed for placement of two coronary bypass grafts.One bypass graft was placed in the lad second bypass graft was placed from the rca (right coronary artery) feeding the obtuse marginal artery.On (b)(6) 2011 patient was admitted to the hospital for afib (atrial fibrillation) and rvr (rapid ventricular heart rate).A ct scan performed of the chest demonstrated bilateral pulmonary embolus.A large pulmonary emboli was identified the right main pulmonary artery causing a near complete occlusion in the right pulmonary artery.Multiple pulmonary emboli were identified the left pulmonary artery.Ultrasound demonstrated a large amount of dvt (deep vein thrombosis) in both legs.The patient experienced multiple episodes of a fib and rvr from (b)(6) 2011.On (b)(6) 2011, the patient¿s rr (respiratory rates) increased (normal adult rr 12-20) to rr of 40 breaths per minute.The oxygen saturation of the blood decreased from 100% to 70%.Ultrasound demonstrated an increased amount of pulmonary embolus in the right and left pulmonary arteries; as well as, thrombus fragmentation.Ultrasound performed on (b)(6) 2011 for the bilateral lower extremities demonstrated that the large amount of dvt previously identified in the bilateral extremities on (b)(6) 2011 had traveled to the pulmonary arteries; no dvt was identified in the bilateral extremities at that time.On (b)(6) 2011, the patient was sent to interventional radiology to have a procedure that would reduce the thrombus fragmentation and deploy an ivc filter.It should be noted that the medical records received did not provide or indicate the manufacturer of the ivc filter that was deployed to the patient.The ivc filter was deployed successfully and without incident.The patient was noted to be stable throughout the procedure.Medical records did not indicate if, what method or where the reduction of thrombus fragmentation was performed.On (b)(6) 2011, at 7: 30pm, the patient heart rate dropped into the 50¿s, as the heart rate slowed the patient became bradycardic.At 7:39pm the patient coded (cardiac arrest).Iv medications were administered to increase the heart rate; however, the patient¿s heart rate flat lined.Multiple rounds of cpr and iv medications were administered to regain the patient¿s heart rate.Despite multiple rounds of cpr and iv medications administered, the patient did not establish a normal sinus rhythm, the code was terminated.The patients time of death was called at 8:27pm, (b)(6) 2011.Medical records indicated that the patient¿s acute decompensation was secondary to pe.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that a vena cava filter was deployed successfully for recurrent bilateral pulmonary emboli post cardiopulmonary bypass.The patient had history of coronary artery disease and was recovering from an open heart cardiopulmonary bypass surgery for two arteries; a critical left main artery that was 99% occluded and an obtuse marginal artery.The cardiopulmonary bypass surgery was performed 21 days prior to the filter deployment.The patient was admitted approximately 12 days post cardiopulmonary bypass and was experiencing recurrent multiple bilateral pulmonary emboli, onset atrial fibrillation and rapid ventricular heart rate.Ct scan performed demonstrated a large pulmonary embolus in the right main pulmonary artery causing a near complete occlusion of the pulmonary artery.Multi-segmental pulmonary embolus was identified in the left pulmonary artery.The patient continued to experience increased pulmonary embolus, atrial fibrillation and rapid ventricular heart rate for the next 10 days.A vena cava filter was finally deployed 21 days post cardiopulmonary bypass without incident and was stable throughout the filter deployment procedure.Ultrasound performed before the filter deployment demonstrated no dvt was identified in the bilateral extremities; dvt was identified by ultrasound nine days prior to the filter deployment.The following day, the patient experienced onset atrial fibrillation and rapid ventricular heart rate, the arterial pressure dropped, and the patient became bradycardic and went into cardiac arrest.Despite resuscitation efforts performed with cpr and iv medications the patient expired.Medical records indicated that the patient's acute decompensation was secondary to pe.The relationship of the ivc filter to the patient death is unknown.

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Image/photo review: no images or photos have been made available to the manufacturer.Conclusion: medical records were provided.Patient allegedly had a history of coronary disease.In (b)(6) 2011 a cardiac catheter procedure allegedly identified a 99% occlusion in the left anterior descending (lad) coronary artery and 100% stenosis in the pulmonary valve heart with retrograde filling.Open heart surgery was performed for placement of two bypass grafts.Approximately two weeks later patient was allegedly admitted to the hospital for atrial fibrillation (afib) and rapid ventricular heart rate (rvr).Allegedly a ct scan demonstrated bilateral pulmonary embolus (pe) while ultrasound identified a large amount of deep vein thrombosis (dvt) in both legs.The patient allegedly experienced multiple episodes of afib and rvr.Approximately ten days later patient had increased respiratory rates and low oxygen saturation.Ultrasound allegedly identified an increased amount of pe in both pulmonary arteries with thrombus fragmentation.Ultrasound demonstrated a large amount of dvt previous identified in the lower extremities had traveled to the pulmonary arteries.The patient allegedly had a procedure to reduce thrombus fragmentation and a filter was deployed.The next day the patient experienced a slowed heart rate and patient became bradycardic.The patient allegedly coded and several medications were administered.Cpr was reportedly performed and additional medications provided.A normal sinus rhythm was not established and the code was terminated.The patient allegedly expired.It was alleged that the patient's acute decompensation was secondary to pe.Based on the medical record review, no filter deficiencies were alleged.There appears to be no correlation between the filter and the patient's death.The investigation is inconclusive.Based upon the available information the definitive root cause for this event is unknown.Labeling review: the current ifu (instructions for use) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.Additional information: relevant tests; other relevant history; report source; (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: G2 FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5515589
• MDR Text Key: 40831608
• Report Number: 2020394-2016-00286
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 12/03/2013

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 Catalogue Number: UNKNOWN G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARGATROBAN, ASA
• Patient Outcome(s): Death
• Patient Age: 58 YR
• Patient Weight: 88