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

Catalog Number UNKAA010

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Foreign Body Reaction (1868); Inflammation (1932)

Event Date 09/17/2013

Event Type  Injury  

Manufacturer Narrative

Based on the information provided the root cause can be associated to the surgeon not removing all of the avitene flour following hemostasis causing the issue (inflamed area of tissue/abscess formation) that presented several months postoperative.As reported the mass was removed without further issue and the patient is reported to have been doing well following the revision procedure.Per the instructions-for-use "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." without a lot number a review of the manufacturing records is not possible.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.Used on patient.

Event Description

It was reported that on (b)(6) 2013 the patient underwent a craniotomy to remove a glioblastoma (brain tumor).During the procedure, the surgeon used avitene for hemostasis.As reported, the surgeon waited several minutes before irrigating and aspirating the remainder of avitene flour.As reported, several months later on (b)(6) 2013 the patient had a follow up brain mri performed which reportedly showed a lesion/mass in the same space the brain tumor was removed.Preoperatively, the surgeon thought regrowth of the tumor.It is alleged that one week later on (b)(6) 2013 the patient underwent a revision procedure which included reopening of the skull incision that had been previously made and the surgeon reportedly discovered there was an inflamed area of tissue/abscess formation that had encapsulated left over avitene collagen.As reported, the tissue was removed and sent to pathology which was reportedly benign.

• 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 sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7569158
• MDR Text Key: 110072151
• Report Number: 1213643-2018-01809
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P80002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• 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