MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN OTOLOGIC REPAIR GRAFT

Catalog Number ENT-OTO-2.5X2.5

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Granuloma (1876); Pain (1994); Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

Date of event not provided by the complainant.Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Implant date not provided by the complainant; reported as end of (b)(6) 2018.Concomitant medical products: grace medical notched titanium bucket handle; gelfoam.510(k): k161000.Based on nci terminology, a granuloma is defined as an inflammatory reaction usually caused by infectious organisms, foreign bodies, or cholesterol deposits.It is characterized by the presence of epithelioid histiocytes and chronic inflammation.Https://ncit.Nci.Nih.Gov/ncitbrowser/pages/concept_details.Jsf?dictionary=nci_thesaurus&version=18.08d&code=c3064&ns=ncit&type=properties&key=586501374&b=1&n=0&vse=null a review of the ifu revealed that ¿inflammation (initial application of surgical device materials may be associated with transient, mild, localized inflammation)¿ was noted amongst the list of potential complications that ¿are possible with the use of surgical device materials in otologic procedures.¿ the device is contraindicated for use in ¿patients with known sensitivity to porcine material¿ as the device is derived from a porcine source.The root cause, of the granuloma, is inconclusive.A stapedectomy typically involves the removal of the stapes bone and a prosthesis is implanted in place of the stapes.In this patient, a grace medical notched titanium bucket handle was implanted to replace the stapes bone.Gelfoam was also used as a packing material.In the absence of the patient having any known sensitivity to porcine material, the biodesign device unlikely contributed to the granuloma.It is possible the patient had a response to other material used during the procedure.

Event Description

Dr.(b)(6) performed a stapedectomy in a male patient in (b)(6) 2018.While elevating a flap, an incidental tear occurred.A biodesign otologic repair graft was utilized instead of harvesting an autologic graft.Gelfoam was placed under the ear drum.A grace medical notched titanium bucket handle was implanted to replace the stapes bone.One week post-surgery, the patient presented with severe ear pain and facial paralysis.The pain and paralysis were unresponsive to steroid treatment.At an unspecified time, the patient went back to surgery.A granuloma was found and excised.The granuloma was irritating a nerve.Post granuloma excision, the patient reportedly had no hearing loss and the facial paralysis was improving.Dr.(b)(6) reported only seeing one other instance of this occurrence in the last twelve years.Dr.(b)(6) was uncertain if the biodesign otologic repair graft was related to the occurrence.

• Brand Name: BIODESIGN OTOLOGIC REPAIR GRAFT
• Type of Device: OTOLOGIC REPAIR GRAFT
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer (Section G): COOK BIOTECH INCORPORATED; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 7889714
• MDR Text Key: 120737498
• Report Number: 1835959-2018-00010
• Device Sequence Number: 1
• Product Code: KHJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENT-OTO-2.5X2.5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention