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Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: 1.Any concurrent use of other products? beriplast p 5ml was sprayed to fix surgicels.2.Lot #? the lot number is unknown.3.What was the intended use of the surgicel? for reinforcement of lung tissue with pneumothorax.4.How much surgicel was used during the procedure? according to the report from the surgeon, 13 pieces of surgicel were used during the procedure.5.Was the surgicel product left in place? was the excess irrigated and removed? according to the report from the surgeon, surgicel products were left in place.6.What is physicians opinion as to the etiology of or contributing factors to this event? the surgeon commented as follows.There was no history of asthma and allergies in the patient, eosinophils tended to increase after the surgery.Dlst was performed with beriplast p and surgicel gauze type.Since 196% positive with surgicel gauze type, i think that it is an allergic reaction of surgicel.7.Was there an alleged deficiency of the surgicel that contributed to the patients post-operative asthma symptoms? the surgeon no commented about that.8.What is the patients current status? as of (b)(6) 2019, breathing difficulty was dissolved and the asthma was controlled with drug therapy.Disease information: reason for use of surgicel: pneumothorax primary disease: lymphangioleiomyomatosis, complications: suspicious of renal angiomyolipoma, previous disease history: none, past drug adverse drug history: none, allergy: none, smoking: past smoking history until (b)(6), 3 cigarettes/day, drinking: none event description: from around 2017, dyspnea during exertion appeared, and an abnormal shadow on the chest was pointed out at the cxp in the medical checkup at the workplace and she was visited the other hospital.On (b)(6) 2017, she was introduced to the department of respiratory medicine of this hospital and was diagnosed with lam.Rapamycin was introduced.She was registered as waiting lung transplant patient, and she was waiting for transplant ((b)(6) 2019).The right pneumothorax began to repeat from around (b)(6) 2019, and it became a policy for surgery on (b)(6) 2019: recurrent pneumothorax occurred, she got emergency hospitalization (nasal cannula 2l, spo2: 98%).(b)(6): drain inserted.(b)(6): operation was performed (vats right whole lung right whole lung pleurodesis).Hospitalized in icu room.(b)(6) left from icu room.(b)(6): difficulty in breathing, decreased oxygenation (reservoir mask 15l) ¿ suspected pe and performed contrast-enhanced ct examination, but no thrombus.Wheezes was observed, asthma was suspected, solu-medrol 125mg + atarax p was administered, inhaled meptin, and respiratory distress disappeared.(b)(6): for bronchial asthma, regular inhalation of saba (meptin) + psl 30 mg / day x 5 days was started.(b)(6): respiratory distress, decreased oxygenation (mask 7l, spo2: 90%) ¿ cxp quickly disappeared with inhalation of meptin without lung collapse.Considering administration of inhaled steroids as an asthma controller, the patient was waiting for transplantation and was not introduced because of fear of fungal infection.A leukotriene antagonist (montelukast 10 mg) was introduced.The following reports were received on the (b)(6) surgical findings.Separate ventilation tube for left 35f intubation, whole hemp.After placement of the epidural anesthesia tube, the left lateral position and the front 5th intercostal drain are cut short and removed immediately before disinfection.Wrap protector mini-mini from the 7th intercostal axilla, wound retractor xs at the 4th intercostal anterior axilla, and separation with chest wall and cord-like adhesion on the outer surface of the upper lobe.Xs under the 6th intercostal scapula.The right lung was blown from the peep1 to 2cmh20 with left single lung ventilation.(1.5 is the best).The lobe is good, and the lung pleura is a large and small cyst with salmon roes like appearance.Middle lobe s5 had atelectasis (suggesting the presence of pulmonary fistula).Efforts were made to protect the lung pleura and thoraco-cotton was moistened with raw food.First, attach (1)surgicel hemostat gauze type (oxidized cellulose) (10 x 20cm) to cover the lung apex from the mediastinal plane above the upper lobe.(2)next, paste it on the outer surface of s2 to s3 so that it also extends to the lower surface of the upper leaf.(afterwards, when the lungs were expanded, the spaces between the lobes were exposed, so add (11)) next, (3)s10 is applied from the back to the diaphragm at the corner of the rib diaphragm.(4)affixed to the outer surface from the back of the lower lobe bottom.(5)affixed so that it covers between the outer surface and the lower lobe from the s6 tip.(6)paste across the outer half of the diaphragm and the outer surface of the bottom.(7)attach between lower leaves s8 to s7, between the leaves.In order to re-inflate the lungs here, the lower surface of the upper lobe was exposed, so (11)surgicel was added.Since there is an exposed part of the pleura on the outer surface of the bottom ward, (12)surgicel was added.Since there is an exposed part between the lower leaves from s6, and (13)surgicel was added.Thus, the lung pleura was almost completely covered.Sprinkle all over with beriplast p 5ml spray to fix them.A 20fr thoracic is placed in front of the chest wall with a separate skin cut from the mini-mini section, and a 19fr break drain is placed over the back from the back to the lung apex.Both wounds are ventilated and each wound is closed in layers.At that time, it was confirmed by drain water seal test that there was no obvious leak.The original drain wound was closed after debridement.Suction with thopaz-10cmh20.Extubating was performed because there was a pulmonary fistula of about 400ml / min even if the posture was changed, but there was no problem with ventilation.However, pco2 60-70mmhg, ph 7.1, and icu entered the ward instead of the ward for reintubation.(left pulmonary edema with left single lung ventilation in left supine position, right operation and surge cell coverage, reduced compliance on both sides, and wound pain, judged to be hypo-ventilated.) doctors comment: there was no history of asthma and allergies in the patient, eosinophils tended to increase after surgery, dlst was performed with beriplast p used during surgery, surge cell gauze type, 196% positive with surge cell gauze type from this point, i think that it is an allergic reaction of surge cells.In cxp, although the original lung is bad and the possibility of eosinophilic pneumonia due to allergy is also increased, it is judged that there is no increase in vital and inflammatory reactions, only asthma, but follow-up is necessary.* regarding (b)(6) asthma attack although it was at a mild level asthma, it was thought that it appeared as a serious symptom due to low respiratory function.See related medwatches: 1.2210968-2019-91372 2.2210968-2021-00420 3.2210968-2021-00421 4.2210968-2021-00430 5.2210968-2021-00429 6.2210968-2021-00428 7.2210968-2021-00427 8.2210968-2021-00426 9.2210968-2021-00425 10.2210968-2021-00424 11.2210968-2021-00419 12.2210968-2021-00417 13.2210968-2021-00418 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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It was reported that a patient underwent a pneumothorax procedure on (b)(6) 2019 and absorbable hemostat was used.The patient was a (b)(6) woman, who complained of dyspnea.Due to lymphangioleiomyomatosis and repeated right pneumothorax while waiting for a brain-dead lung transplant, thoracoscopic total pleurocoverage was performed.The whole pleura was coated with 13 absorbable hemostats.The operation time was 2 hours and 38 minutes.Dyspnea and decreased spo2 developed on postoperative day 6.There were no obvious abnormalities in imaging tests, and wheeze was heard, and bronchial asthma was diagnosed.Symptoms improved with drip infusion of steroid and inhalation of procaterol.Oral administration of antiallergic drugs was also started, but an asthmatic attack recurred on postoperative day 9, requiring inhalation of procaterol, and no further attacks were observed.The patient had no past history of bronchial asthma or allergy.Since an increase in eosinophils was noted after surgery, a drug induced allergy was suspected.No new drug was started in the perioperative period, and absorbable hemostat and plasma fraction preparation used during surgery were considered as suspect.Since absorbable hemostat was positive in the lymphocyte stimulation test, the patient was diagnosed with drug-induced allergy.In pneumothorax surgery, there are many opportunities to perform pleural covering using absorbable hemostat to prevent recurrence.Although its usefulness has been reported, there have been no reports of allergy.Absorbable hemostat is often used for secondary pneumothorax due to a serious background disease.Therefore, sufficient attention should be paid to the risk of severe ventilatory failure even in mild asthma attack.Additional information was requested.
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