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

Catalog Number SURGICELUNK

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

Patient Problem Foreign Body Reaction (1868)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The single complaint was reported with multiple events.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number(s).Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative patient consequences described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Can you identify the product code and lot number of the product that was used in each procedure? can specific patient demographics initials / id; age or date of birth; bmi; gender; 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? citation: rev esp med nucl imagen mol.2020; if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via a journal article: title: a foreign body reaction to surgicel® simulating lymph node relapse in the pet/ct after lung cancer surgery: 3 new cases.Author(s): j.López sánchez and m.T.Gómez hernández.Citation: rev esp med nucl imagen mol.2020; https://doi.Org/10.1016/j.Remn.2020.08.008.The objective of this report is to warn about the possibility of false positives in oncology surveillance pet/ct in relation to foreign body reactions to surgicel.Below are 3 clinical cases with false positive findings after lung resection for lung cancer in relation to foreign body reactions after the intraoperative application of oxidized regenerated cellulose (surgicel®).A (b)(6)-year-old male patient who underwent a lower left lobectomy plus lymphadenectomy via robotic-assisted thoracic surgery (rats) for squamous cell carcinoma stage pt2an1m0.Surgicel® was applied to the lymphadenectomy surgical beds in areas 5 and 7.At 8 months post-surgery, he presented radiological and metabolic suspicion of lymph node relapse due to a 16mm lesion with a suvmax of 13.4 in the subaortic region.A biopsy of the lesion was performed by videothoracoscopy, and the definitive histological analysis showed a necrotic reaction associated with acellular material.A (b)(6)-year-old male patient who underwent a lower right lobectomy plus lymphadenectomy via robotic-assisted thoracic surgery (rats) for squamous cell carcinoma stage pt2an0m0.Surgicel® was placed in the lymphadenectomy surgical bed in area 7.One year later, he presented suspected lymph node relapse due to a 40mm mass in the subcarinal region with a suvmax of 17.An endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) was performed with a negative result for malignancy and subsequent tumor biopsy by thoracotomy, with a definitive diagnosis of fibrohistiocytic reaction, without evidence of malignancy.A (b)(6)-year-old female patient who underwent a median lobectomy plus lymphadenectomy via robotic-assisted thoracic surgery (rats) for squamous cell carcinoma stage pt3n0m0.Surgicel® was placed in the lymphadenectomy surgical bed in area 4r.At 3 months, she presented radiological and metabolic suspicion of lymph node relapse in the right paratracheal region (suvmax: 3.8).Ebus-tbna of the 4r region was performed, which obtained a fibrinous material without cellularity of the lymph node, which was negative for malignancy.Surgicel® is an absorbable hemostatic agent composed of oxidized regenerated cellulose whose complete absorption occurs 7-14 days after its application, depending mainly on the amount used5.Probably, if a lesser amount of surgicel® was applied or if it was withdrawn once adequate hemostasis was achieved, the result could be complete absorption of the exogenous material and a lower inflammatory reaction.Likewise, it would be useful if a record was kept of where and how this material was used for cancer follow-up.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10939243
• MDR Text Key: 219321227
• Report Number: 2210968-2020-09542
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2020

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
• Device Catalogue Number: SURGICELUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR