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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL

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LIFECELL UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Unspecified Infection (1930); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
Article citation: asaad, malke, et al. ¿acellular dermal matrix provides durable long-term outcomes in abdominal wall reconstruction. ¿ annals of surgery, publish ahead of print, 2020, doi:10. 1097/sla. 0000000000004454. This mdr is being reported as a multiple event type for serious injury. The corresponding author is not willing to provide additional clinical information. The device was not returned for evaluation and the lot number remains unknown; therefore, internal investigation into the event could not be performed. Based on the reported information, a relationship between the event and strattice cannot be determined. If additional information is reported, a follow up adverse event report will be submitted. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
During a literature review, an article was received entitled: "acellular dermal matrix provides durable long-term outcomes in abdominal wall reconstruction: a study of patients with over 60 months of follow-up. " background: ventral hernia repair(vhr) is one of the most commonly performed procedures in the united states, but studies assessing the long-term outcomes of vhr using biologic mesh are scarce. Methods: conducted a retrospective cohort study of patients who underwent awr using either porcine adm(padm) or bovine adm(badm) from 2005 to 2019. We analyzed the full cohort and a subset of our population with minimum long-term follow-up(ltf) of 5 years. The primary outcome measure was hernia recurrence(hr) and secondary outcomes were surgical site occurrences(ssos). Results: identified a total of 725 awrs (49. 5% padm, 50. 5% badm). Mean age was 69±11. 5 years and mean body mass index was 31±7 kg/m2. Forty-two percent of the defects were clean at the time of awr, 44% were clean-contaminated, and 14% were contaminated/infected. Mean defect size was 180±174 cm2, mean mesh size was 414±203 cm2. Hernia recurred in 93 patients(13%), with cumulative hr rates of 4. 9%, 13. 5%, 17. 3%, and 18. 8% at 1, 3, 5, and 7 years, respectively. There were no differences in hr(p
=
0. 83) and sso(p
=
0. 87) between the two mesh types. Ssos were identified in 27% of patients. In our ltf group (n
=
162), the hr rate was 16%. Obesity, bridged repair, and concurrent stoma presence/creation were independent predictors of hr; component separation was protective against hr. Literature concluded: the current study reports the longest follow-up outcomes to date for awr with adm. Given the complexity of our patients, biologic mesh provides very favorable awr outcomes that are comparable to, if not better than, those observed using synthetic mesh in a patient population with similar comorbidities and defect characteristics. Biologic mesh remains an excellent and reliable long-term option for complex awr.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key10869206
MDR Text Key217161318
Report Number1000306051-2020-00054
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/19/2020 Patient Sequence Number: 1
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