MAUDE Adverse Event Report: COOK BIOTECH ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT; HYBRID GRAFT

Catalog Number C-HYB-20X30

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Seroma (2069); Hematuria (2558)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

Date of event not provided by the complainant.Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Implant date only specified as (b)(6) 2017.The lot number was unobtainable and therefore a review of device history was not performed.The ifu notes to ¿place the device in maximum possible contact with healthy, well-vascularized tissue to encourage cell ingrowth and tissue remodeling.¿ seroma formation is noted in the ifu as one of the ¿possible adverse reactions with the use of any prosthesis.¿ additionally, the ifu states ¿complications such as delayed wound infection, hernia recurrence and the need for re-operation should be expected in patients who are critically ill.¿ the ifu suggests that the device should overlap ¿the surrounding tissue by at least 4-5 cm in all directions.¿ lastly, the ifu advises the user to ¿place closed suction drains for 2-6 weeks.Remove when output is less than 20 ml/24 hours for at least two (2) consecutive days or until drain is dry.¿ the root cause of the sis degradation, in the absence of an infection, is likely due to the presence of a persistent seroma.The appearance of the sis described as ¿pus¿ and ¿sinewy¿ is a typical appearance of the sis as it degrades and does not incorporate.The patient¿s compromised ability to heal, due to the diabetes and liver cirrhosis, also could influence a lack of incorporation of the device.The root cause of the seroma formation is likely due to drains only being placed in the subcutaneous space and not near the graft.Again, the patient¿s compromised ability to heal could have also contributed to the persistent seroma.Lastly, the hernia defect was noted as 15 x 30 cm and a 20 x 30 cm device was implanted.This does not seem like it would have provided the recommended 4-5 cm overlap in all directions.Such a lack of overlap could negatively affect incorporation and performance of the device.

Event Description

Dr.(b)(6) placed a zenapro c-hyb-20x30, in (b)(6) 2017 for repair of a recurrent midline incisional hernia.This was a clean case which also included a lysis of adhesions.The hernia defect was 15 x 30 cm and there was atrophy of the right rectus muscle.The zenapro device was placed in an intraperitoneal fashion with the rough side facing anterior.The smooth side was facing the viscera.Fixation sutures were placed circumferentially with no fixation in the middle of the device.The abdominal wall and subcutaneous tissue was anterior to the mesh.Primary closure of the fascia was performed.There were drains placed in the subcutaneous space, but no drains were placed near the mesh.On the first post-op visit, the patient complained of abdominal pain and blood in her urine.A large seroma was identified around the graft.Interventional radiology placed a drain above the mesh.Further clarification with the cook area representative revealed that dr.(b)(6) mentioned the blood in the patient's urine as a side note about the patient's comorbidities and disease state.Dr.(b)(6) did not seem to correlate the blood in the urine as being caused or contributed to by the zenapro.On (b)(6) 2017, the second post op visit, the patient still complained of abdominal pain.The seroma had not subsided.Ct scans revealed there was concern in the area of the graft and decided to reoperate to explant the zenapro.Dr.(b)(6) reopened the abdominal wall via the midline incision.Granulation tissue was found to have formed over the bowel.The sis portion of the zenapro was degraded and reported as "turned to pus" which left large sections of the synthetic mesh exposed.The degraded sis was also described as "sinewy, strand, and necrotic." the entire device was explanted.Dr.(b)(6) placed a wound vac to promote further healing.Further clarification with the cook area representative revealed that this was a clean case when zenapro was placed.The wound, at the time of reoperation, was not infected.Dr.(b)(6) indicated he did not usually use drains with zenapro and that had not created any issues in the past.He was under the impression that drains were not needed with zenapro due to the perforations in the graft.He stated he understood the likelihood of seroma formation and assumed that situations like this had occurred before with the use of zenapro.The cook area representative explained in detail, to dr.(b)(6), that best practices strongly suggest the placement of drains.Additional conversations between the cook area representative and dr.(b)(6) revealed that dr.(b)(6) reported there was major sagging, of the zenapro device, due to a lack of fixation in the middle of the device.For an open repair, placing fixation in the middle of the device is generally the standard.Dr.(b)(6) was not complaining that the sis degradation was more of an issue than the seroma formation, or vice versa.Dr.(b)(6) feedback related to the procedural failure overall.As reported to customer relations: since surgery when zenapro was placed (about 3 months ago), patient was experiencing abdominal discomfort and pain.Intraperitoneal placement: seroma formation did not subside within 3 months; drains inserted multiple times.Friday morning patient underwent surgery to explant mesh.All the biologic had turned to a gooey puss that was an ¿absolute mess¿.Dr.(b)(6) used a vac to remove what was left of the graft.

• Brand Name: ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT
• Type of Device: HYBRID GRAFT
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 6632889
• MDR Text Key: 77282278
• Report Number: 1835959-2017-00002
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-HYB-20X30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• 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: 64 YR