MAUDE Adverse Event Report: SURGIFLO NGEN LYO THROMBIN 2ML; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2994
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Local Reaction (2035); Swelling/ Edema (4577)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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: the patient was re-admitted to the hospital 7-10 days post op and did not undergo reoperation.The surgiflo was worked into a corner (pushed to one side), and aspirated.The patients were immediately fine afterward.The full volume of the product, 8ml, was being used prophylactically.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Is this a male or female? what is the age of the patient? has the patient had previous spine surgery? can specific patient demographics initials / id; date of birth; bmi; 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 of study drugs be provided? what is the surgeon¿s opinion as to the relationship of the product to the symptoms? on what date was the index surgery? what was the level of the anterior cervical fusion? during the surgical case, were there complications that extended the length of the surgery? did the patient have surgical hardware, bone graft or surgical plate implanted? on what type of bleeding was surgiflo hemostatic matrix kit with thrombin (product code 2994, abbreviated surgiflo 2994)) used? how many units of surgiflo 2994 were used during the surgery? do you have the lot number of the surgiflo 2994 being used? did the surgeon remove excess surgiflo 2994 when hemostasis had been achieved? did the surgeon use any other hemostats during surgery? if yes, what brands were they? were they removed when hemostasis had been achieved? how was the immediate post-op period in pacu? please let us know if complications occurred.On what post-op day was the patient discharged home? patient was then admitted through the er.On what post-op day was the patient admitted through the er? on what day was the re-surgery? it is noted that patient ¿also experienced some difficulty swallowing¿.Was the patient diagnosed with dysphagia due to the acdf surgery? did the patient undergo any clinical examinations for the diagnosis of dysphagia ¿ such as digital nasendoscopy, fees and/or vfss or any other investigations.Please let us know the results it is noted that the patient experienced ¿post op reaction of redness and swelling at the incision site below the skin surface¿.Did the patient undergo mr scan or any other investigations prior to surgery? please let us know the results.During the re-surgery, was there any sign of hematoma formation? how is the patient doing now? discharged? complications? what was the indication for using the product? we noted that it is the same surgeon who reports of five similar cases.Is the surgeon a new user of surgiflo 2994? has the surgeon undergone product training in the use of surgiflo 2994? is this hospital a recent conversion account from floseal to surgiflo 2994? has the surgeon raised an opinion as to a relationship of surgiflo 2994 and the post-op complications? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an anterior cervical disc fusion procedure on an (b)(6) 2021 and absorbable hemostat was used.The patient experienced a post op reaction of redness, swelling at the incision site below the skin surface, and some difficulty swallowing.The patient was admitted through the er.The surgeon re-opened the incision site where the surgiflo poured out, was cleaned, and sutured the wounds with no further issues.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: (b)(6) 2021.Additional information was requested, and the following was obtained: the surgeon confirmed that the product was being used prophylactically and not to treat active bleeding.He also stated that the excess product was not removed.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/7/2021.Investigation summary: no complaint sample was received.In conclusion surgiflo® hemostatic matrix kit with thrombin is not for prophylactic use - the device is indicated for "surgiflo® hemostatic matrix, mixed with thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical".The remaining conclusion is unchanged and still valid: excess surgiflo® hemostatic matrix should be removed once hemostasis has been achieved, because of the possibility of dislodgment of the device or compression of other nearby anatomic structures.Only the minimum amount of surgiflo® hemostatic matrix needed to achieve hemostasis should be used.Once hemostasis is achieved, any excess surgiflo® hemostatic matrix should be carefully removed.The use of surgiflo® hemostatic matrix kit with thrombin product code 2994 in this event is evaluated to be off-label.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: SURGIFLO NGEN LYO THROMBIN 2ML
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• MDR Report Key: 11449477
• Report Number: 2210968-2021-70004
• Device Sequence Number: 3126065
• Product Code: LMF
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2021
• Report Date (Section F): 03/09/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2994
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/09/2021
• Date Report to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/22/2021; 05/04/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/11/2021; 05/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention