| Catalog Number SGC01ST |
| Device Problems
Physical Resistance (2578); Device Operates Differently Than Expected (2913)
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| Patient Problem
Foreign Body In Patient (2687)
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| Event Date 08/18/2014 |
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Event Type
Injury
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Event Description
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This mitraclip report is filed for the steerable guide catheter (sgc) that was left in the anatomy, considered a foreign body.It was reported that on (b)(6) 2014, a mitraclip procedure was performed on an elderly patient with a degenerative mitral regurgitation grade of 4.The clip delivery system (cds) and sgc were prepared for use as per the instructions for use (ifu).The transseptal puncture was measured at 3.2 cm despite being maximally superior and posterior in the fossa ovalis.There was some difficulty inserting the sgc into the left atrium (la) and the physician used some time to manipulate the steering +/- knobs and anterior/posterior movements in order to achieve access.The transesophageal echocardiogram (tee) quality was poor, but when the sgc was in the left atrium, the dilator was retracted into the sgc and the guide wire was retracted into the dilator as per the ifu.The physician began to aspirate the sgc, but after a short time, he could no longer aspirate.At this point it was not possible to visualize the guide accurately due to poor tee quality.The physician stopped aspirating and attempted to retract and torque the guide, but all attempts at aspirating failed.The sgc was retracted into the right atrium with no ability to aspirate.The sgc was removed completely from the anatomy.Once removed, the sgc was able to be aspirated without issue and was flushed with no sign of obstruction.It was surmised that the inability to aspirate from the sgc was due to the sgc tip being against tissue both when the device was in the la and the ra.
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Manufacturer Narrative
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(b)(4).Patient age is estimated as only the year of birth ((b)(6)) was received.Event description continued: the poor imaging made it extremely difficult to visualize the tip of the sgc.The transseptal puncture was re-performed and the sgc was de-aired again and inserted without issue with better tee quality.The first cds (10336205/07) was inserted as per the ifu.The sgc + steering knob was applied to optimize alignment and the clip was advanced into the left ventricle.Using the medial and lateral adjustment, after approximately five attempts to grasp the leaflets with the clip, both leaflets were successfully grasped reducing the mr grade from 4 to 3 with a main jet located lateral to the clip.Prior to clip deployment, the leaflet assessment was performed as per the ifu.During the gripper line removability test, the flush was increased.Prior to removing the gripper line, the patient experienced tachycardia and a drop in blood pressure.Air was noted in the left anterior descending artery (lad) on the echocardiogram.There was no sign of air in the system and all flushes and 3-way taps were functioning normally.It was not apparent where the air came from when seen in the lad and the air dispersed after approximately two minutes.Inotropes were administered stabilizing the patient.The gripper line was removed deploying the clip.The cds was removed from the anatomy.A second clip (10352135/15) was prepared for use as per the ifu and was planned to be placed laterally to the first clip.The cds was inserted into the la.The patient became unstable with a drop in blood pressure and tachycardia.An increase of inotrope was administered.The second clip was placed on the leaflets lateral to the first clip.After leaflet assessment, clip deployment was performed as per the ifu.After the actuator knob was turned 9 times counter-clockwise, it was retracted, but the clip did not release from the cds.The actuator knob was turned 5 more times and the clip appeared to release, but when the delivery catheter (dc) handle was retracted, the clip moved with it.The patient became increasingly difficult to keep stabilized.The decision was made to remove gripper line as this was considered to be only possibility to be hindering deployment.The gripper line was removed without issue, but the clip still moved with the cds.The cds steering m knob was turned to remove the medial curve in an attempt to release the clip at which point the clip and cds jumped laterally.The clip was now seen to be at a 90 degree angle to the cds and appear to have been torn from the leaflets.The patient condition deteriorated as a major right hemothorax and small pericardial effusion was observed.A thoracotomy was performed and approximately 1.5 liters of blood (thought to be arterial) was drained.The source/cause of the bleeding could not be determined by the physician.The chest tube was left in the patient.The anesthesiologist commented that when the chest tube was placed in the right chest a lot of blood came out immediately and continued to pour out.A blood transfusion was performed.The physician did not want to remove the cds and sgc from the anatomy as the risk of the clip embolization was too high.The cardiac surgeon would not perform surgery as the patient was considered as an unacceptable risk (elderly, (b)(6), sternotomy with an unknown source of bleeding).Protamine was administered and all other medication was stopped.The sgc and cds were taped to the patient and not removed.After the patient was transported to the intensive care unit, later that evening, the patient expired.Cause of death was hemorrhagic shock.An autopsy is pending.The steerable guide catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other devices (two cds) referenced are filed under separate medwatch reports.
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Event Description
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Subsequent to the initial report, additional information received indicated that the autopsy and procedural reports are being retained at the hospital and are unavailable for review.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The steerable guide catheter (sgc) was not returned for investigation.Procedural images were received.The analysis of this complaint will be an assessment of the manufacturing records, complaint history and information provided to abbott vascular.Potential causes for difficulty inserting the guide (physical resistance) into the patient anatomy are, but not limited to, patient conditions (such as anatomical morphology/pathology, associated comorbidities, and disease state), user technique/procedural conditions (transseptal puncture techniques) or manufacturing anomalies.As part of the mitraclip manufacturing process, all devices are subject to visual, dimensional and functional inspection to verify product quality.Review of the lot history record confirmed this device passed all in-process and final acceptance activities, including verification that the outer diameter of guide tip met specification and the device functioned as intended.There were no manufacturing nonconformities issued to this lot that would have contributed to the reported event.A query of the electronic complaint handling system did not reveal any other incidents reported for this lot.There were no reported device issues while functionally inspecting the sgc during device preparation, which is an indication that the device was functioning properly prior to use.There is no indication that the manufacture of the device contributed to the reported event.With respect to the patient condition, procedural conditions and/or user technique, physical resistance with the anatomy may be influenced by the anatomical morphology/pathology of the septum or the transseptal puncture technique.The information provided in the case details stated that during insertion of the guide, it took time to manipulate the steering +/- knob and anterior/posterior movements in order to achieve access.It was noted that the transseptal puncture was measured at 3.2 cm despite being maximally superior and posterior in the fossa ovalis.Further clarification from the site also stated that the intra-atrial septum was on the thicker side and therefore it was difficult to advance the sgc.In addition, the transesophageal echocardiogram (tee) imaging was poor during sgc advancement.After the sgc was removed and re-prepped, the same transseptal puncture was used for the reinsertion of the sgc.In this case, it is likely that a combination of the patient anatomy and the suboptimal imaging contributed to the difficult sgc insertion (physical resistance) into the anatomy.Based on the information reviewed, the reported physical resistance appears to be related to patient/procedural conditions and not an indication of a product deficiency.In regards to the reported inability to aspirate the sgc during use, the information provided stated that when the dilator and guide wire were retracted into the guide per the instructions for use (ifu), the physician could no longer aspirate the sgc.At this point, it was not possible to visualize the guide accurately due to poor tee quality.After all attempts at aspirating failed, the sgc was retracted into the right atrium (ra) with no ability to aspirate.The sgc was removed completely from the anatomy.Once removed, the sgc was able to be aspirated without issue and was flushed with no sign of obstruction.This indicates that there were no leaks in the system that would have contributed to the difficulty aspirating the device.It was surmised that the inability to aspirate was due to the sgc tip being against tissue both when the device was in the left and the right atrium.The poor imaging made it extremely difficult to visualize the tip of the sgc.The sgc was de-aired again and inserted without issue with better tee quality.In this case, it is likely that the guide came into contact with the wall of the atrium due to the suboptimal imaging and therefore resulted in the inability to aspirate the guide.Based on the information provided, the reported device operates differently than expected appears to be related to procedural conditions/user technique.There does not appear to be any indication of a product quality deficiency.The reported information and returned images (combination of still and cine 2d and 3d tee images) were reviewed by an abbott vascular senior medical advisor.The reviewer stated that this patient had symptomatic severe mitral regurgitation, was frail and hemodynamically unstable so was not a surgical candidate and therefore underwent the mitraclip procedure.During the case, there was difficulty with optimal transseptal puncture due to patient anatomy and suboptimal imaging.There was concern of air entry during introduction of the steerable guide catheter (sgc), but this could not be confirmed on the images provided.After positioning of the first clip, a lateral jet was observed, so it was decided to implant a second clip.During removal of the gripper line, there was concern for air entry into the left anterior descending artery (lad [riva]).This was confirmed with the images provided.A second clip was positioned on the leaflets to reduce the lateral jet, but with the inability to deploy the clip the mitral regurgitation (mr) grade increased back to at least 3 based on the images provided.The presence of the effusion which was seen at the end of the procedure could not be confirmed.The suboptimal distance of the transseptal puncture was demonstrated on the images provided, but the measurement stated in the report could not be confirmed.The reviewer concluded that there is evidence that the adverse events were not attributable to the device based on the cines and still images provided for this incident.The air embolism in the lad was secondary to difficulty with visualization and creation of vacuum when the sgc was against tissue.Additionally, the reported hemodynamic instability (tachycardia, hypotension) were associated with air embolism.There is no evidence of device deficiency or malfunction.Additionally, given the hemothorax was in the right pleural cavity and the mitraclip system is introduced into the left atrium, it is not possible the device was causal or contributory to the significant hemothorax, and unlikely to be causal or contributory to the pericardial effusion.Given the steps of the procedure, the guide wire, which is introduced after transseptal puncture, was likely the causal device.The death was secondary to hemorrhagic shock associated with hemothorax and the underlying frail and prohibitive risk status of the patient.The other devices and adverse events reported in this event have been reported under the manufacturer reference numbers (b)(4).
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Search Alerts/Recalls
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