MAUDE Adverse Event Report: ETHICON INC. SURGICEL ABSORBABLE HEMOSTAT UNKNOWN; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Visual Disturbances (2140); Respiratory Tract Infection (2420); Ptosis (2620)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device not returned.This report is related to a journal article; therefore no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.Additional information was requested, and the following was obtained: please provide the following patient demographic information, if available: weight, bmi at the time of index procedure? the patient was a (b)(6) year-old man.What was the date of index surgical procedure? nasal endoscopic tumor removal.What were the diagnosis and indication for the index surgical procedure? inverted papilloma.Tumorous lesions in the left nasal cavity.Please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.No further information is available.Was there any intraoperative concurrent use of other products? no further information is available.Please confirm that the product code is 1961.The product code is unknown.What is the lot number? no further information is available.Where was the surgicel used (on what tissue)? there was bleeding from the cavernous sinus, and hemostasis was obtained by placing oxidized cellulose (surgicel).How much surgicel was used during the procedure? no further information is available.Was the surgicel product left in place? was the excess irrigated and removed? =>no further information is available.Has any surgical or medical intervention been performed? administration of antibiotics and steroids was started, and neurological symptoms improved.What is physician¿s opinion as to the etiology of or contributing factors to this event? it was commented that we could not find a specific cause, and it was inferred that the disease was caused by infection from the paranasal sinuses after the operation of sinus papilloma and reactive inflammation to hemostatic agents.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative course? =>no further information is available.What is the patient¿s current status? no further information is available.No further information will be provided.Citation: the 122nd annual meeting of the orl society of japan., 124(4)629.

Event Description

It was reported via a journal article: we experienced a case in which eyelid ptosis and eye movement disorder appeared 1 month after surgery for sinus papilloma and led to a diagnosis of hypertrophic pachymeningitis about 3 months later.We report this case with a review of the literature.The patient was a (b)(6) year-old man who had a tumor lesion in the left nasal cavity.Biopsy led to a diagnosis of inverted papilloma, and transnasal endoscopic tumorectomy was performed.The tumor base was around the lateral optic canal in the sphenoid sinus, and when the excavation of the internal carotid artery of the optic nerve was performed, there was bleeding from the cavernous sinus, and hemostasis was obtained by placing oxidized cellulose (surgicel).Approximately 1 month after surgery: left eyelid ptosis and eye movement disorder developed.Detailed mri showed a contrast effect in the orbital apex, and nasal optic neuritis due to inflammation, spongiform pulsation, residual tumor, etc.Were suspected.Administration of antibiotics and steroids was started, and neurological symptoms improved.Three months after the onset, mri examination revealed enlargement of the contrast effect area from the orbital apex to the dura mater, leading to a diagnosis of hypertrophic pachymeningitis.We searched for the cause of the secondary thick pleurisy, but we could not find a specific cause, and it was inferred that the disease was caused by infection from the paranasal sinuses after the operation of sinus papilloma and reactive inflammation to hemostatic agents.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/21/2021.Additional information received was the english translation of the journal article attached in mw # 2210968-2021-07209.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12305396
• MDR Text Key: 266012157
• Report Number: 2210968-2021-07209
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR