MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. AVITENE; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Catalog Number 1010010

Device Problem Insufficient Information (3190)

Patient Problem Visual Impairment (2138)

Event Date 12/18/2016

Event Type  Injury  

Manufacturer Narrative

Based on the events as reported the user did not follow the recommendations outlined in the instructions-for-use (ifu) supplied with the product.As he placed the avitene flour in the area of the optic nerve and the avitene was not removed prior to closing the site.The precautions section of the instructions for use that are provided with the product states, "avoid packing avitene tightly in cavities, especially within the bony enclosure of the cns or within other relatively rigid cavities where swelling may interfere with normal function or possibly cause necrosis." only that amount of avitene (mch) necessary to produce hemostasis should be used.After several minutes, excess material should be removed; this is usually possible without the reinitiation of active bleeding.Any excess avitene (mch) not removed at the time of surgery may either present itself as a (recurring) mass or a (space occupying) lesion or it may lead to a foreign body reaction that may present with or without clinical signs and symptoms as a recurring mass or lesion or postoperative abscess formation upon imaging.Imaging may initially not be capable of distinguishing the difference.Removal of excess material, ideally performed upon conclusion of the initial procedure, typically resolves all signs and symptoms." a review of the manufacturing records was performed and found that the lot was manufactured to specification.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that a surgeon in (b)(6) used bard avitene flour in conjunction with another non bard/davol hemostat product in an open craniotomy for removal of a pituitary tumor on (b)(6) 2016.As reported the non bard/davol hemostat was removed from the site.Then it is reported that the bard avitene flour was compressed into a peanut sized ball and wedged into the space, leaving the material in the patient.As reported the avitene flour was not removed prior to closing, nor was the site irrigated to remove excess material.Following the procedure the patient experienced complete blindness.The patient was taken into surgery on (b)(6) 2016 and the surgeon removed as much of the avitene as was possible and irrigated the site.The patient is reported to have regained some vision, the surgeon report that he suspects the reported blindness was due to avitene's compression on the nerves.

• Brand Name: AVITENE
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): MEDCHEM PRODUCTS, INC. -1223089; 160 new boston street; woburn MA 01801
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6223454
• MDR Text Key: 63883736
• Report Number: 1213643-2017-00004
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P80002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Catalogue Number: 1010010
• Device Lot Number: WBARFD14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2016
• 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; Disability