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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN SURGISIS ENTEROCUTANEOUS FISTULA PLUG

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COOK BIOTECH BIODESIGN SURGISIS ENTEROCUTANEOUS FISTULA PLUG Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Obstruction/Occlusion (2422)
Event Type  Death  
Event Description
Publication/single institution outcome of minimally invasive enterocutaneous fistula management utilizing the biodesign fistula plug. Abstract. Purpose: to report the outcomes of the biodesign fistula plug as an alternative treatment for enterocutaneous fistulae by presenting our institutional experience from 2013 to 2020. Materials and methods: a retrospective review of all attempted fistula closures utilizing the biodesign fistula plug at a single institution from 2012 to 2020 was performed under irb approval and in compliance with hipaa. Patient demographics were obtained including age at the time of the procedure, etiology, location of the fistula, history of malignancy, prior chemotherapy or radiation, and history of prior surgery or other interventions. Patient follow-up was performed through (b)(6) 2020 to evaluate for fistula closure, complications, or subsequent treatments. Results: there were 25 patients who underwent 35 biode-sign fistula plug placements. Of these, 7 procedures were successful, defined as closure of the fistula, and 28 procedures were unsuccessful, defined as persistent fistula output or requiring further intervention on the ec fistula. There were 7 major complications, sir classification d
=
3, e
=
2 and f
=
2. No statistically significant risk factors were found predicting fistula plug failure although there was a trend towards patients with malignancy having unsuccessful outcome (p
=
0. 057). The average number of procedures for patients with successful closure was 1. 4 versus 4. 22 for those with unsuccessful closure. The average time to plug failure was 27. 8 days (range 3¿163 days), and the average time to fistula closure following plug placement was 21. 4 days (range 14¿30). Conclusion: enterocutaneous fistulae are complex and morbid with no good treatment options. These findings demonstrate the biodesign fistula plug can be successful in select patients, however, should be used with great caution due to high rate of failure and complications including two patient deaths. The pr will capture and investigate the following patient outcome: deceased within 30 days of plug placement after discharge home on hospice with a new small bowel obstruction.
 
Manufacturer Narrative
Date of death not reported in publication. Date of event not reported in publication. Lot number not provided in the publication. Udi unknown due to no reporting of lot number in publication. Device expiration date unknown due to no reporting of lot number in publication. Rpn not specified in publication efp. Implant date only specified in publication as in the range of 01/01/2012 - 07/01/2020. Device manufacture date unknown due to no reporting of number in publication. Investigation included: a review of the publication, communication with an author of the publication, meeting of the incident investigation committee (iic), and a review of the biodesign enterocutaneous fistula plug ifu fp0069-01j. On 05/23/2022, cbi's medical education and clinical research director contacted the corresponding author of the publication. Per that phone conversation, the patient's involved in the study were frail and had advanced underlying conditions. The patient complications were noted to be related to the patient's underlying health condition(s) and the plug was not directly implicated as the cause. This patient had lymphosarcoma treated with external-beam radiation and chemotherapy. On 05/25/2022, cbi's incident investigation committee (iic) met to discuss the reported occurrence and determine reportability. Thee iic determined the occurrence should be reported. Per the ifu, the user should use caution when implanting the device in a recently irradiated field. The user should also ensure that the gastrointestinal tract is free of obstruction distal to the fistula prior to placement of the enterocutaneous fistula plug. Bowel obstruction is a known potential complication. The root cause of the patient's bowel obstruction is inconclusive. It is inconclusive if the device caused or contributed to the bowel obstruction. However, based on the phone conversation with the corresponding author, the occurrence is likely related to the patient's underlying condition. Per the publication, the patient was noted to have had prior radiation to the site of the fistula plug placement. Also, the publication states that the obstruction "might have been secondary to fistula plug placement, given the close proximity in time and location, however the patient did have underlying malignancy. ".
 
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Brand NameBIODESIGN SURGISIS ENTEROCUTANEOUS FISTULA PLUG
Type of DeviceENTEROCUTANEOUS FISTULA PLUG
Manufacturer (Section D)
COOK BIOTECH
1425 innovation place
west lafayette IN 47906
Manufacturer (Section G)
COOK BIOTECH
1425 innovation place
west lafayette IN 47906
Manufacturer Contact
tony foldenauer
1425 innovation place
west lafayette, IN 47906
7654973355
MDR Report Key14516604
MDR Text Key292785765
Report Number1835959-2022-00001
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082682
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/26/2022 Patient Sequence Number: 1
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