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

Catalog Number SURGICELUNK

Device Problem Material Integrity Problem (2978)

Patient Problem Granuloma (1876)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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.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.Was the case discussed in this article previously reported to ethicon? if yes, please provide complaint reference number.Does the surgeon believe that ethicon product surgicel absorbable hemostat involved caused and/or contributed to the adverse events described in the article? if yes, please provide event details including: initial procedure date procedure name specific patient demographics (initial/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? ) where was the procedure performed? event date ethicon product involved; product code and lot number was there any medical or surgical intervention performed to treat the granuloma (re-operation; prescription steroids; antibiotics prescribed)? if so, please clarify.Patient pre-existing conditions/other relevant patient history/concomitant medications are any devices available for evaluation? can you identify the product code and lot number of the product that was used? citation: journal of clinical urology 1¿3; doi: 10.1177/2051415820930619.

Event Description

It was reported via a journal article: title: diagnostic challenge of a radiological mass post partial nephrectomy in a patient with a single functioning kidney: surgicel granuloma authors: siobhan duffy, flora rodger, sioban fraser and grenville oades citation: journal of clinical urology 1¿3; doi: 10.1177/2051415820930619.This case report presented a 61-year-old female with recurrent urinary tract infections and an ultrasound demonstrating an atrophic left kidney and prominent lower pole calyx in the right kidney.A subsequent computed tomography (ct) urogram revealed a 4 cm mass postero-medially within the right kidney.The biopsy findings were indeterminate, but after multidisciplinary team (mdt) discussion the patient proceeded to open right partial nephrectomy.A single surgicel (ethicon) bolster was used intra-operatively for hemostasis and post-operative recovery was uneventful.A ct scan of the chest, abdomen and pelvis was performed 6 months post-operatively due to dyspnoea.This showed no evidence of disease recurrence or metastases, but there was a fluid collection at the site of the resection, presumed to be post-operative change.At 1 year, ct showed a persistent area of low attenuation at the site of the resection as before but with new central enhancement.These changes were not considered to be typical of expected post-operative change and were concerning for recurrence.Two ct-guided biopsies taken 2 months apart did not confirm malignancy and following mdt discussion, the decision was made for continued radiological surveillance.The 3¿6 monthly imaging between 18- and 33-months post operation demonstrated static appearances.At 3 years post procedure, both magnetic resonance imaging and ct scans were suggestive of a small increase in size of the lesion.A further ct guided biopsy again did not demonstrate malignancy but had amorphous eosinophilic material with a rim of chronic inflammatory cells including multinucleate giant cells and fibrosis.Stains for micro-organisms, tuberculosis and amyloid were negative.After more than 6 years post procedure, continued surveillance has shown a relatively static picture with minimal increase in the size of the lesion and the internal calcification.This lesion most likely represents a surgicel granuloma (n=61-year-old female).Although foreign material has never been seen histologically, the chronic inflammatory infiltrate and presence of multinucleate giant cells is considered supportive of this diagnosis.In addition, over this 6-year period there is no radiological or histological evidence of disease recurrence aside from the persistent lesion itself.The results of this case report showed that the investigation and management of surgicel granuloma, although rare, can cause significant physical and psychological morbidity for the patient and can result in substantial financial cost.Also, surgeons we should be mindful of the potential complications of leaving surgicel in situ and really consider whether it is truly necessary to do so.

• 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: 10932690
• MDR Text Key: 219152874
• Report Number: 2210968-2020-09489
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SURGICELUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 12/02/2020
• 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 Age: 61 YR