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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACELL, INC. GENTRIX SURGICAL MATRIX PLUS

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ACELL, INC. GENTRIX SURGICAL MATRIX PLUS Back to Search Results
Model Number MSPL1015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Seroma (2069); Obstruction/Occlusion (2422)
Event Date 11/07/2017
Event Type  Injury  
Manufacturer Narrative
This mdr is being submitted due to the reported occurrence of adhesions and bowel obstruction three months after the initial placement of the acell device.Upon further discussions with the explanting surgeon on 4/10/2018, it was determined that the patient developed a seroma shortly post operatively requiring drainage, and it was felt that the presence of the obstruction may have been caused not only by the recurrent adenocarcinoma, but also due to the implantation of the device during the hernia repair.The acell device may have led to the formation of adhesions to the surgical closure; which caused the development of the bowel obstruction, that necessitated operative intervention and partial device explantation.The explanted device was evaluated by hospital pathologist which revealed the presence of adherent omentum containing recurrent adenocarcinoma.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with fda, state, local, and acell's operating procedures.There were no reports of device failure at the time of initial surgery.
 
Event Description
Patient had a ventral hernia repair surgery conducted on (b)(6) 2017.An exploratory laporatomy on (b)(6) 2017 revealed the patient had multiple adhesions and multiple loops of small bowel stuck together with an acell surgical sheet.The adhesions were removed, the bowel resected and the acell surgical sheet was partially explanted.Hospital pathology results indicated the presence of adenocarcinoma in mesenteric tissue a follow up ct discovered diffuse adenocarcinoma throughout the bowel.The surgeon at the time believed that the complications were due to the spread of cancer post-operatively, not due to the acell surgical sheet.On 4/10/2018 acell received notification during a follow-up call between chief science officer and surgeon, it was discovered that patient developed a seroma post operative which was drained percutaneously.Additionally, it was the surgeon's opinion the diffuse cancer was the primary reason for adhesion formation.The development of adhesions to the surgical closure, which included an acell surgical sheet, may have led to the development of the bowel obstruction discovered on (b)(6) 2017, which necessitated operative intervention.It was this clarification on (b)(6) 2018 that prompted the reconsideration of this event from customer feedback based upon the primary reason for the complication being cancer, to reportable based upon the potential involvement of the device in the development of the bowel obstruction.
 
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Brand Name
GENTRIX SURGICAL MATRIX PLUS
Type of Device
GENTRIX SURGICAL MATRIX PLUS
Manufacturer (Section D)
ACELL, INC.
6640 eli whitney dr.
columbia MD 21046
Manufacturer (Section G)
ACELL, INC.
6640 eli whitney dr.
columbia MD 21046
Manufacturer Contact
barry brainard
6640 eli whitney dr.
columbia, MD 21046
8034870493
MDR Report Key7494927
MDR Text Key107631613
Report Number3005920706-2018-00001
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00386190001240
UDI-Public(01)00386190001240(17)190630(10)009504
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date06/30/2019
Device Model NumberMSPL1015
Device Catalogue NumberMSPL1015
Device Lot Number009504
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/10/2018
Initial Date FDA Received05/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age63 YR
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