MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number UNKNOWN

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

Dates conservatively estimated.Although a portion of the device was explanted on (b)(6) 2016, the rest of the device remains implanted.Method of evaluation: manufacturing review: review of information as reported to lifecell.Pathological evaluation: the portion of the explanted device was returned to lifecell for evaluation.Pathological gross analysis describes a 3 x 2 x 2cm irregular firm, gray and yellow fibrofatty tissue fragment.Microscopic diagnosis revealed nodules of acellular collagen graft material seen delimited by well-developed fibrosis and intermixed chronic inflammatory infiltrate.Focally, some acute inflammation is seen along with foreign body reaction.Necrobiosis of the acellular collagen graft material is also present in areas.Elastin vvg stain supports this impression; b&b gram stain and gridley fungal stains are negative for organisms.There was extremely irregular scarring and fibrosis surrounding portions of the collagen graft material that never properly incorporated.The presence of "bunched up" strattice material is consistent with failure to incorporate for various reasons rather than thinning of the strattice graft material itself.Results of evaluation: no failure detected: pathological examination shows no relationship between the gross description of the strattice intra-operatively and the microscopic observation of the explanted tissue.There was extremely irregular scarring and fibrosis surrounding portions of the collagen graft material and is consistent with failure to incorporate rather than thinning of the strattice graft material itself.Conclusion code: known inherent risk of procedure.This patient's re-herniation occurred approximately 1 year after the initial repair with strattice.Pathological examination shows no relationship between the gross description of the strattice intra-operatively and the microscopic observation of the explanted tissue.There was extremely irregular scarring and fibrosis surrounding portions of the collagen graft material and is consistent with failure to incorporate rather than thinning of the strattice graft material itself.Although the cause cannot be determined, patient factors like radio or chemotherapy, poor surgical technique or improper device placement could contribute to nonincorporation.In addition, the patient's history of prior hernia repair may have contributed to the re-herniation.The adhesions discovered intra-operatively are considered an incidental finding and is a complication related to intra-abdominal surgery with or without the use of an acellular dermal matrix.The ifu warns that potential adverse events typically associated with surgical mesh materials and their implantation procedures include a recurrence of tissue defects and adhesions.Based on a pathological evaluation of the returned specimen, a relationship between the hernia recurrence and the adhesion formation following the implantation of strattice could not be conclusively determined.The lot associated with his complaint is unknown.Without the associated lot number, a device history record review was unable to be performed.Lifecell has made multiple attempts to obtain lot number information.If it is received, a follow up report will be submitted.

Event Description

It was reported that this is a (b)(6) patient with a medical and surgical history of enterocutaneous fistulas, parastomal hernia, sigmoidectomy with stoma, refashioning of stoma, deep vein thrombosis, pulmonary emboli, hysterectomy, fibroids, pulmonary wedge resection, radiotherapy and chemotherapy.In (b)(6) 2014, the patient underwent an incisional hernia repair with strattice.Subsequently, in (b)(6) 2015 the patient re-herniated and was returned to surgery on (b)(6) 2016 for repair.During the procedure, the strattice was noted to be lax and thinned out.The device was also adhered to the bowel on both sides and the anterior abdominal wall.The surgeon explanted a portion of the strattice and removed the adhesions with difficulty.The patient was repaired with polypropylene in an onlay technique and negative pressure incision management.The explanted portion of the strattice was returned to lifecell for evaluation.

• Brand Name: STRATTICE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): LIFECELL CORPORATION; one millennium way; branchburg NJ 08876
• Manufacturer Contact: paul arrendell ; one millennium way; branchburg, NJ 08876 ; 9089471110
• MDR Report Key: 6120235
• MDR Text Key: 60650394
• Report Number: 1000306051-2016-00074
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 73 YR