MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number 2025002EU

Device Problem Material Disintegration (1177)

Patient Problem Hernia (2240)

Event Date 04/09/2014

Event Type  Injury  

Manufacturer Narrative

Date of event: date is estimated.Concomitant medical products: another strattice device (lot not reported) was implanted in april of 2012.Therapy date is estimated.(b)(4).Qa investigation into lot sp100023 resulted in no remarkable findings with no other complaints reported against the lot and no deviations or nonconformances with product or patient impact revealed during processing.Lot sp100023 was terminally sterilized and met all qc release criteria.It should be noted that the patient's recurrence of hernias occurred approximately 2 years after each procedure with the implantation of strattice.During each revision procedure, the strattice devices were reported to be partially incorporated.Pathological examination of the partially explanted device did not show evidence of graft disintegration.As per the ifu, potential adverse events typically associated with surgical mesh materials and their implantation procedures include a recurrence of tissue defects.Due to the limited information regarding the patient's previous herniations, the device as a contributing factor to the events cannot be ruled out.Lifecell has attempted to follow up for additional information of the previous events.If additional information is received, a follow up report will be submitted.

Event Description

It was reported that this is a female patient with a past surgical history of total abdominal hysterectomy, bilateral salpingo-oophorectomy (removal of tubes and ovaries), bilateral pelvic and para aortic lymph node sampling, infra colic omentectomy (removal of fatty tissue covering the bowel) on (b)(6) 2011.In 2012 the patient underwent adjuvant chemo therapy.The timeline of events for this patient are as listed: in (b)(6) 2012, the patient underwent a hernia repair with strattice implanted intraperitoneally in an onlay technique by this same surgeon.The lot number used in this case was not reported.In 2014, the patient had a recurrence of incisional hernia.On (b)(6) 2014, the patient was returned to surgery for repair of hernia with strattice lot sp100023-073 implanted in an underlay technique and right hemicolectomy.The strattice from the previous surgery in 2012 was explanted, but noted to be partially incorporated.In (b)(6) 2015, the patient had a recurrence of large ventral hernia.On (b)(6) 2016, the patient underwent an elective repair of ventral incisional hernia.The reherniation was reported to have occurred just outside the area of the strattice from the previous surgery in 2014 (lot sp100023-073).Intra-operatively, the device was noted to have disintegrated in the central portion of the graft with residual scattered islands of strattice remnants and a very thin film was left in its place while other areas appeared intact and vascularized.The surgeon explanted this area of the device to return to lifecell for evaluation.A new piece of strattice was implanted in an underlay technique and prolene mesh in an onlay technique.Currently the patient is recovering well.

• Brand Name: STRATTICE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): LIFECELL CORPORATION; one millennium way; branchburg NJ 08876
• Manufacturer Contact: glin garcia ; one millennium way; branchburg, NJ 08876 ; 9089471041
• MDR Report Key: 5899770
• MDR Text Key: 52853558
• Report Number: 1000306051-2016-00056
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2015
• Device Model Number: 2025002EU
• Device Catalogue Number: N/A
• Device Lot Number: SP100023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2013
• 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
• Treatment: STRATTICE
• Patient Outcome(s): Required Intervention