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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

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BAYER HEALTHCARE LLC ESSURE DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE Back to Search Results
Model Number ESS305
Device Problem No Information
Event Date 01/22/2015
Event Type  Death  
Manufacturer Narrative

Follow-up information received on 19-mar-2015. It was reported the autopsy was done on (b)(6); the cause of patient's death is still under investigation. The complete report (histology slides and toxicology results) are expected. Reporter stated that the physical examination during the autopsy revealed a puncture of the uterus, but the role, if any, that this may have played in the patient's death is currently unknown. Final autopsy report was received on 09-apr-2015: the autopsy was performed on (b)(6) 2015. The patient was (b)(6); at external examination her weight was (b)(6) and height(b)(6). Internal examination and autopsy summary of findings included: hemoperitoneum (peritoneal cavity contained 550 ml of liquid blood); perforation of posterior superior right fundus of uterus during attempted cannulation of right fallopian tube (0. 5 cm defect); adjacent structures, including the urinary bladder, the rectum, and the major vascular structures on either side of pelvis were intact and had no associated hemorrhage. Status post insertion of essure insert into left fallopian tube. Mild cerebral edema; there was no lesions of the cortical gray ribbon, white matter, or deep gray matter. There was no epidural, subdural or subarachnoid hemorrhage. Moderate pulmonary edema; bilateral pleural effusions, 35 ml each; slight pericardial effusion, 20 ml. The heart had usual configuration; the foramen ovale had a probe patent, valve competent defect that attained a maximal diameter of 0. 3cm. The coronary arteries were normally distributed and widely patent throughout their lengths. There was no myocardial inflammation or increased myocardial fibrosis at microscopic examination. As incidental findings a papillary carcinoma of upper pole of left lobe of thyroid gland, cholelithiasis and cholesterolosis of gallbladder were found. Toxicology analysis of subclavian blood was positive for oxycodone 28 micrograms (therapeutic concentration) and lidocaine (not quantified). A chest x-ray was performed at the morgue and hospital without evidence of air embolus. The manner of death was concluded as accident and the cause of death considered as probable paradoxical air embolism due to hysteroscopic tubal occlusion procedure with perforation of uterus in a patient with patent foramen ovale. Additionally, the medical examiner concluded the patient likely died as a result of an air embolism that entered her venous system during essure procedure, since the right side of the fundus of the uterus was perforated, resulting in the exposure of uterine veins to air. According to her, while postmortem radiographs did not show an accumulation of air in the right side of the heart, the patient had a patent foramen ovale; which likely permitted a right-to-left shunt of the embolus into the arterial circulation (subject's death was likely secondary to an air embolus that gained access to the subject's arterial circulation via her patent foramen ovale). She stated the perforation of the uterus did not result in injury of contiguous structures or of significant vascular injury. While some blood was in the abdomen (the peritoneal cavity), this quantity of blood was relatively small and would not have been expected to have resulted in hemorrhagic shock. Company causality comment: this spontaneous case report refers to a (b)(6) female patient who had an attempt of essure insertion; the procedure included premedication with percocet and a paracervical block with 1% lidocaine. Hysteroscopy was performed with liquid distension media. A few minutes into the procedure, she was noted to be shaking a lot and experienced generalized seizure activity prior to sudden cardiac arrest. There was no shortness of breath, chest pain, headache or signs of confusion prior to the seizure activity. An autopsy was performed and revealed normal cns anatomy with mild cerebral edema, no hemorrhage, no watershed or generalized cerebral infarcts. Cardiac examination demonstrated normal anatomy with a patent foramen ovale which is reported in 25% of autopsies, patent coronary arteries, and no inflammatory changes. The uterus contained a 0. 5 cm defect on the right side of the fundus consistent with a uterine perforation secondary to the hysteroscopic procedure. Structures adjacent to the uterine fundus including the major vascular structures were intact and without associated hemorrhage. The abdomen contained 550 ml of blood and fluid which according to the evaluator, would not have been expected to have resulted in hemorrhagic shock. X-rays were performed and no air was detected within the heart at the hospital and at the morgue examination. Toxicology revealed a serum oxycodone level of 28ug/l which is a therapeutic level consistent with administration of percocet about 1 hour prior to the procedure. Lidocaine was reported as being detected but not quantified. Reportedly, the final diagnosis of the medical examiner is probable paradoxical air embolism due to hysteroscopic tubal occlusion procedure with perforation of uterus in patient with patent foramen ovale. Establishing a definitive diagnosis of air embolism can be difficult even in a post-mortem setting. Two preconditions must exist for venous air embolism to occur: a direct communication between a source of air or gas and the vasculature and a pressure gradient favoring the passage of air/gas into the circulation. Different hysteroscopic procedures are associated with significantly different risks of air embolism. Hysteroscopic myomectomy and endometrial ablation are procedures where uterine vessels may become injured and exposed thereby setting up a condition for communication between a source of air or gas and the vasculature. Gas may be introduced by the electrosurgical vapors, by entrapment of air into the surgical field with repeated passes of the hysteroscope into the uterus, or by using a gas such as carbon dioxide as the distension media. In contrast hysteroscopic procedures which do not involve surgical removal of intra-uterine material have a very low prevalence of clinically significant air/gas embolus. The hysteroscopic procedure involving essure placement with the fallopian tubes is typically performed with liquid distension media and without additional intra-uterine procedures, as it was in this case. During hysteroscopy for essure placement, visualization of the anatomical structures is accomplished by the flow of liquid through the hysteroscope into the uterine cavity. When uterine perforation occurs, the pressure within the uterus drops immediately and the liquid distension media flows into the peritoneal cavity. Therefore, following uterine perforation the pressure gradient required to force air/gas into the vasculature will not be present as any blood from the area of the uterine perforation along with the liquid entering through the hysteroscope and any air/gas will flow towards the lowest pressure which is into the peritoneal cavity. This will result in termination of the surgical procedure due to the inability to maintain uterine distension. Post-mortem evaluation did not reveal compromise of any significant vascular structures. It is unknown as to whether the perforation preceded or occurred following movement of the patient as a consequence of her shaking or seizure activity. Lidocaine can cause muscle twitching, convulsions and cardiac arrest. Its effects can be potentiated by oxycodone. The possibility exists that these agents may have contributed to the clinical events in this patient. Bayer has inquired as to whether measurement of a serum level of lidocaine is available. In summary, a definitive cause of death could not be established in this case. There may be several contributing factors including possible air embolism, and the anesthetic agents used.

 
Manufacturer Narrative

Follow-up and additional information received on (b)(6) 2015: toxicological results for the decedent's lidocaine level were received and listed as being "therapeutic": lidocaine level was 2 mg/l (+/- 0. 6mg/l). Sample was received at the laboratory on (b)(6) 2015. Company causality comment: this spontaneous case report refers to a (b)(6)-year-old female patient who had an attempt of essure insertion; the procedure included premedication with percocet and a paracervical block with 1% lidocaine. Hysteroscopy was performed with liquid distension media. A few minutes into the procedure, she was noted to be shaking a lot and experienced generalized seizure activity prior to sudden cardiac arrest. There was no shortness of breath, chest pain, headache or signs of confusion prior to the seizure activity. An autopsy was performed and revealed normal cns anatomy with mild cerebral edema, no hemorrhage, no watershed or generalized cerebral infarcts. Cardiac examination demonstrated normal anatomy with a patent foramen ovale which is reported in 25% of autopsies, patent coronary arteries, and no inflammatory changes. The uterus contained a 0. 5 cm defect on the right side of the fundus consistent with a uterine perforation secondary to the hysteroscopic procedure. Structures adjacent to the uterine fundus including the major vascular structures were intact and without associated hemorrhage. The abdomen contained 550 ml of blood and fluid which according to the evaluator, would not have been expected to have resulted in hemorrhagic shock. X-rays were performed and no air was detected within the heart at the hospital and at the morgue examination. Toxicology revealed a serum oxycodone level of 28ug/l which is a therapeutic level consistent with administration of percocet about 1 hour prior to the procedure. Lidocaine was reported as being detected but not quantified. Reportedly, the final diagnosis of the medical examiner is probable paradoxical air embolism due to hysteroscopic tubal occlusion procedure with perforation of uterus in patient with patent foramen ovale. Establishing a definitive diagnosis of air embolism can be difficult even in a post-mortem setting. Two preconditions must exist for venous air embolism to occur: (1) a direct communication between a source of air or gas and the vasculature and (2) a pressure gradient favoring the passage of air/gas into the circulation. Different hysteroscopic procedures are associated with significantly different risks of air embolism. Hysteroscopic myomectomy and endometrial ablation are procedures where uterine vessels may become injured and exposed thereby setting up a condition for communication between a source of air or gas and the vasculature. Gas may be introduced by the electrosurgical vapors, by entrapment of air into the surgical field with repeated passes of the hysteroscope into the uterus, or by using a gas such as carbon dioxide as the distension media. In contrast hysteroscopic procedures which do not involve surgical removal of intra-uterine material have a very low prevalence of clinically significant air/gas embolus. The hysteroscopic procedure involving essure placement with the fallopian tubes is typically performed with liquid distension media and without additional intra-uterine procedures, as it was in this case. During hysteroscopy for essure placement, visualization of the anatomical structures is accomplished by the flow of liquid through the hysteroscope into the uterine cavity. When uterine perforation occurs, the pressure within the uterus drops immediately and the liquid distension media flows into the peritoneal cavity. Therefore, following uterine perforation the pressure gradient required to force air/gas into the vasculature will not be present as any blood from the area of the uterine perforation along with the liquid entering through the hysteroscope and any air/gas will flow towards the lowest pressure which is into the peritoneal cavity. This will result in termination of the surgical procedure due to the inability to maintain uterine distension. Post-mortem evaluation did not reveal compromise of any significant vascular structures. It is unknown as to whether the perforation preceded or occurred following movement of the patient as a consequence of her shaking or seizure activity. Lidocaine can cause muscle twitching, convulsions and cardiac arrest. Its effects can be potentiated by oxycodone. Following the fatality on (b)(6) 2015 a subclavian blood sample was received on (b)(6) 2015 and subsequently analyzed for lidocaine. Use of local anesthesia requires that the effects remain local. Administration of subcutaneous lidocaine has a relatively slow uptake into the systemic circulation. The level of 2 mg/l within the timeframe from the onset of the procedure until cardiovascular arrest suggests unintentional intravascular (either intravenously or intra-arterially) administration. Once in the systemic circulation, the local anesthetic will be distributed to all regions of the body in proportion to their blood flow. The high lipophilicity of lidocaine facilitates rapid uptake. There is rapid uptake of drug into the heart and cns. These tissues unload slowly. Lidocaine is a non-selective na+ channel blocker which inhibits cardiac conduction leading to widening of the qrs complexes. At higher doses it produces major disturbances in cardiac rhythm, most commonly ventricular tachycardia. In the cns lidocaine initially inhibits the cns inhibitory pathways enabling unopposed excitation manifesting as muscle twitching and convulsions. As the dose increases inhibition of both excitatory and inhibitory pathways are inhibited resulting in cns depression. These cns changes followed by cardiac arrest were observed in this case in the sequence described that is associated with increasing levels of anesthetic. Inadvertent intravascular administration of local anesthetic agents results in the attainment of peak concentrations within a few minutes followed by rapid decline thereafter. Thus a level of 2. 0 mg/l obtained following attempts at cardiopulmonary resuscitation in the peripheral circulation is consistent with the acute attainment of lidocaine exposure to the cns and cardiovascular pacemaker tissues sufficient to result in convulsions and cardiac arrest. Thus, the possibility exists that intravascular lidocaine administration may have led to the clinical events in this patient. However, considering they occurred in association with essure insertion procedure, causality with the suspect insert cannot be excluded.

 
Event Description

This is a spontaneous case report received from a medical doctor in united states on (b)(6) 2015 which refers to a (b)(6) female patient who died during essure (fallopian tube occlusion insert) insertion procedure. Additional information received from medical doctor on (b)(6) 2015. A female patient with no known medical conditions presented for elective placement of essure for permanent contraception. Prior to the procedure, she was administered toradol (30 minutes prior) and percocet (60 minutes prior). Vital signs were reported as normal. The patient was prepped for the procedure and lidocaine 1% was administered in a paracervical block. The left fallopian tube was cannulated and the essure device deployed without incident. A second bag of distention fluid was started. The opening to the right fallopian tube was not well visualized. The operator gently pushed against the side of the uterus (described by the surgeon as probing) adjacent to the opening of the right fallopian tube with the tip of the essure catheter and advanced the catheter up to the black line. The patient suddenly coded. Prior to coding the patient was noted to be shaking a lot and experienced generalized seizure activity. Autopsy (verbal report) noted a 5mm perforation in the right cornual region adjacent to the tubal ostia with no vascular damage. The pathologist reported that the cause of death does not appear to be hemorrhagic shock and is not related to the procedure. Follow-up received on (b)(6) 2015 from physician's office manager: essure lot number was reported as d01976 (expiration date: 31-aug-2017). The final autopsy report is not available yet. (b)(4). Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint. Typically, we would inspect the micro-insert to look for any manufacturing deficiencies. In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements. We are unable to confirm any quality defect or device malfunction at this time. Death is not a known failure mode related to essure. Medical assessment: this ptc was initiated due to a request for confirmation of quality. The reported adverse events are not indicative of a quality deficit per se. No further ae case reports have been received to date in relation to the reported batch. No batch signal could be identified. The batch documentation of the reported batch was reviewed. No complaint sample was provided for a technical investigation. The technical assessment concluded "unconfirmed quality defect". In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report. Company causality comment: this medically confirmed, spontaneous case report; refers to a (b)(6) female patient who had an attempt of essure (fallopian tube occlusion insert) insertion and during this procedure she convulsed and died (suddenly coded during insertion) despite cardiopulmonary resuscitation attempts. Preliminary autopsy results showed a perforation in the cornual region of the uterus near the right tube and 500 cc of blood in abdomen. The reported uterine perforation was considered serious due to medical importance and is listed according to essure's reference safety information. Uterine perforation may occur with any trans-cervical intrauterine procedures (e. G. Hysteroscopy, curettage) including insertion of a fallopian tube occlusion insert (essure). Therefore, the reported uterine perforation was regarded as related to the suspect insert. This case was considered an incident, as although the exact cause of patient's death was not clarified (autopsy final report is pending), an association with the suspect insert cannot be excluded, since death occurred during essure placement procedure. A product technical analysis was performed and concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report. Follow-up information (final autopsy results) is being sought.

 
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Brand NameESSURE
Type of DeviceDEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
Manufacturer (Section D)
BAYER HEALTHCARE LLC
milpitas CA
Manufacturer (Section G)
BAYER HEALTHCARE LLC
1011 mccarthy blvd.
milpitas CA 95035
Manufacturer Contact
k. shaw lamberson
100 bayer blvd., p.o. box 915
whippany , NJ 07981-0915
MDR Report Key4531887
Report Number2951250-2015-00125
Device Sequence Number1
Product CodeKNH
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 08/12/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberESS305
Device LOT NumberD01976
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/28/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/20/2015 Patient Sequence Number: 1
Treatment
TORADOL (KETOROLAC TROMETHAMINE)
PERCOCET [OXYCODONE HCL, PARACETAMOL] (OXYCET)
LIDOCAINE (LIDOCAINE) , 1 %
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