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As no lot number was provided, a ship history report (shr) was generated for item number (h965251860) in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The three lots obtained through the shr were (5304591, 5357559 and 5370128).A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the angiovac product family and the failure mode "patient injury/death." no adverse trend was indicated.No sample was received for evaluation as the event report states that, "the angiovac portion of the procedure went well, without equipment-related complication." the patient death was not indicated to be related to a device malfunction, but rather to a "bleeding issue from the pacemaker pocket." as stated in the directions for use supplied with the angiovac, regarding adverse events: "this device, as do all extracorporeal blood vessel devices, has possible side effects, which include but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques.These may occur if the instructions for use are not followed.Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/ cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited to: death, pulmonary embolism".(b)(4).
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The following information was provided by angiodynamics' clinical specialist who was present at the procedure: patient history: female (b)(6), referred from (b)(6) by dr.(b)(6), for evaluation and recommendation for a problem related to her pacemaker system.The patient's scans, notes and other spot information, have been reviewed.The patient had a right sided system, which are around 20 years old and had failed attempts at extraction in 2011.The leads are currently capped.She has a left-sided dual chamber pacemaker and leads, which were implanted in 2011 and she is pacemaker dependent with underlying complete heart block.Her battery is nearing completion.In addition, she has developed a superior vena cava syndrome, related to narrowing of the superior vena cava, related to her previous surgeries and indwelling leads.The patient is very uncomfortable at her face is swollen.She apparently has a relatively normal ejection fraction.The patient had a coronary angiogram in 2016, which showed no critical lesions, but was complicated, by bleeding in the right femoral artery pseudoaneurysm, which was treated with surgery.She still has a host of other comorbidities.Recommendation is extraction of all the leads if possible, placement of superior vena cava stent, which will be done with dr.(b)(6) and placement of new pacing system.The patient's risk of an adverse outcome is about 10%, but continuing the way she's going now, is dangerous.Concurrence has been obtained from the (b)(6) physicians, as well as from the patient and her daughter.Pre case plan: the patients leads will be accessed at both subclavian veins.The generator will be removed, the leads freed from the pocket and the pocket capsule will be excised.The pockets will then be covered, while access for the av is achieved.A 26fr.Sheath will be placed in the rfv, and an 8fr.Sheath will be placed in the lfv, along with a 20fr.Arterial cannula.The av cannula will be advanced up to the ivc/ra junction, where optimal flow will be established.The av will then be advanced into the ra under tee guidance, where the leads will be de-bulked.The cannula will then be positioned in the svc, for an attempt to de-bulk material, around the leads.Once this is accomplished, the cannula will be, repositioned in the ra, to provide protection, when the leads are extracted.Once the leads are extracted, a stent will be placed in the svc.The goal for this procedure, is to remove all the material from the leads and svc, then provide embolization protection, during the lead extraction.Pre op vitals: ecg shows a paced rhythm with a heart rate of 60 bpm.Arterial pressure is 123/66/89, nibp is 94/60/75, temp is 36.0, etco2 is 34% and spo2 is 100%.Procedure: the patient's leads were accessed at both subclavian veins.The generator was freed from the left subclavian pocket, the leads were freed from the pockets and the pocket capsules was excised.Both pockets were then covered, while access for the av was achieved.A 26fr.Gore dryseal sheath was inserted into the rfv.An 8fr.Mac sheath was inserted into the lfv, along with a 20fr.Edwards lifesciences optisite arterial reinfusion cannula in the left common femoral vein (lfv).An initial act was performed and the result was 156 seconds.25,000u of heparin was administered to the patient, resulting in a procedural act of 493 seconds.A st.Jude medical pacel temporary pacing catheter was inserted through the 8fr.Sheath and positioned in the rv.The av cannula was inserted through the dryseal sheath and positioned in the lower ivc.The cannula balloon was inflated to 1.5 atm.And both the balloon and cannula funnel were verified under fluoroscopy to be expanded.The cannula was then advanced up to the ivc/ra junction, over a 180cm.035 lunderquist wire.The centrifugal pump was then turned on and a maximum flow rate of 2.2 l/min was achieved.The av cannula was then advanced into the ra under tee guidance and multiple passes were made along the leads.Flow rates were constant at 1.7 l/min, with small pieces of material, entering the bubble trap filter.This material was white/grey in color and fibrous.The av cannula was then positioned in the mid ra, in preparation for the leads to be extracted.During the av lead de-bulking, the left sided pocket has an issue with continual bleeding.Both physicians regularly stopped what they were doing, to consult, investigate and address the source of the bleeding problem.Sutures as well as continual use of the plasma blade, were utilized in an attempt to stop the bleeding.A cook medical evolution rl 13fr.Control-rotation dilator sheath set was advanced over the atrial lead, in the left sided pocket, allowing the lead to be freed and extracted.The device was then advanced over the ventricular lead, allowing the lead to be removed.This process was then repeated for both leads on the right side.Flow rates during this process, remained constant at 1.9 l/min.Throughout the procedure, only a small amount of material was captured in the bubble trap filter.There was a large amount of material, still attached to the leads, after they were extracted.A small area of material remained in the ra, along the septal wall, which was visualized with tee.Dr.(b)(6) said, that because the av cannula had been been on/across the material numerous times, he was not concerned with perusing the small piece.The av cannula was pulled back to the dryseal sheath.The cannula balloon was deflated, the centrifugal pump was turned off and the cannula was extracted.The valve of the dryseal sheath was checked to ensure that material had not fallen out of the cannula during extraction.The av cannula was then placed into a basin of saline, the centrifugal pump was turned back on and the remaining blood inside the circuit was returned back to the patient.Total pump time was 23 minutes.Vital signs at this are: ecg is a paced rhythm with a heart rate of 60 bpm.Arterial pressure is 118/61/84, nibp is 92/58/73, temp is 35.7, etco2 is 34% and spo2 is 100%.Patient is stable at this time.Dr.(b)(6) is preparing for the svc stent placement.A 5fr.Merit medical ka2 impress catheter, was inserted through the mac sheath and a hand injected venogram was performed.The venogram showed a stenosis in the svc, extending up into the right brachiocephalic vein.The ka2 catheter was extracted and a volcano visions pv ivus catheter was inserted.The ivus catheter was advanced up to the right brachiocephalic vein, which measured 13mm and when pulled back to the svc, measured 15mm.The ivus catheter was extracted and an 8.0mm x 40mm x 80cm abbott vascular armada balloon was then inserted.Two dilations were performed along the stenosis.The balloon was extracted, then the mac sheath was exchanged for a 12fr.45cm glide flexor sheath.Once again, the procedure was stopped to address bleeding from the left sided pocket.A boston scientific 16mm x 60mm x 75cm wallstent was then inserted and deployed along the stenotic area.A 14mm x 40mm x 80cm abbott vascular armada balloon was then insert and two inflations were performed, to ensure the stent was deployed appropriately.The balloon was extracted and a post venogram, showed good apposition of the stent, to the vessel wall.The ivus catheter was re-inserted and imaging verified correct stent placement and wall apposition.At this time, the patient's pressure began to drop.The anesthesiologist gave the patient epinephrine and chest compressions were started.A venogram was performed during the code, which showed the svc open with good flow.Two units of blood were infused during the procedure, prior to the patient coding.Chest compressions were maintained for 18 minutes during the code, before it was called.After the code was called, i went over and spoke to the anesthesiologist.I asked him, if the patient coding, was possibly due to the remaining material embolizing? he said that the code was not due to the material, but was due to a volume issue.The anesthesiologist said (and showed me) that he had given the patient 8 units of blood during the procedure.He said that he couldn't get ahead of the volume problem, regardless of what he tried.I also spoke to dr.(b)(6) after the procedure.I asked him what his perspective was concerning the case.He said that the av portion of the procedure, went well and as expected.He also said "i still can't figure out where the patient was bleeding from".Dr.(b)(6) said that he would let me know what they find out.(further communication from the clinical specialist stated that, "the complication was a bleeding issue from the pacemaker pocket." post op vitals: ecg shows a paced rhythm with a heart rate of 60 bpm.Arterial pressure is 65/32/43, nibp is 94/60/75, temp is 34.4, etco2 is 34% and spo2 is 97%.Case successful (av portion).Patient passed.Case start: 11:13 case end: 13:49 · initial act: 156 sec.+25,000u of heparin= 493 sec.· flow rate: 2.2 l/min · pump time: 23 min · fluoro time: 19.7 min.
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