MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for BIODESIGN HERNIA GRAFT C-SLH-8H-13X22 manufactured by Cook Biotech.
[42425876]
Date of event not provided by the complainant. A review of the device history records indicated the device was manufactured to specifications. The root cause of the adhesion(s) is inconclusive. However, many factors can influence and contribute to adhesion formation including, but not limited to a patient's tendency to form adhesions, an abdominal procedure, any damage to the bowel during the initial surgery, excessive tissue incisions, surgical technique, excessive handling of viscera, history of prior surgeries, post-operative activities, nutrition, and the overall state of health of the patient. Adhesion formation is listed as a potential complication in the ifu. Additionally, the ifu notes that? Care should be taken to avoid damage to the graft when loading laparoscopically. It is recommended to load through a 10 mm or larger port.? In relation to answering the cook sales representative and surgeon? S question, adhesion is identified as a risk with the biodesign hernia graft. The graft would have to have been significantly disrupted on the surface in contact with bowel, and would have to be somewhat dry in order to be able to present an abrasion concern. The adhesion would come as a result of the device abrading the bowel and creating inflammation in the healing response. The device biochemistry would not increase the likelihood of adhesion just through damage / disruption of the graft during delivery. The damage would have been more likely to occur as a result of the lap port or device hitting bowel and disrupting it (bowel) during, what may have been a greater than normal level of difficulty when delivering the device.
Patient Sequence No: 1, Text Type: N, H10
[42425877]
Dr. Isabella mor performed a laparoscopic sugarbaker procedure, on (b)(6) 2016, and placed a biodesign hernia graft c-slh-8h-13x22 to treat a parastomal hernia in an (b)(6) female patient. The surgeon had attended a cook parastomal hernia repair workshop the day prior to this case and was reportedly familiar with the procedure. Approximately five (5) 0 pds full thickness transfacial sutures were placed using a novapass suture passer. Approximately eight (8) protack stainless steel spiral tacks were also used to affix the hernia graft to the peritoneum. During the procedure, the surgeon had significant difficulty introducing the hernia graft through the laparoscopic port and into the patient's abdomen. The graft was soaked in saline, as per recommendations, then rolled and inserted into the 12 mm laparoscopic port. The hernia graft became stuck in this port a few times and a significant amount of force was applied with the grasper to push the hernia graft through the port. The hernia graft eventually had to be inserted by removing the port and placing the hernia graft directly through the skin incision. The patient was noted to have had four (4) hospital admissions during the month following the surgery due to complaints of nausea and discomfort. During this time, the patient was diagnosed with hyponatremia (low sodium concentration in the blood), but was otherwise okay. On (b)(6) 2016, the patient was readmitted to the hospital with discomfort and nausea. A scan identified a bowel obstruction. On (b)(6) 2016 the patient underwent a reoperation and was found to have small bowel adhered to the hernia graft and contributing to the bowel obstruction. The adhesion(s) was removed and the hernia graft was left intact. The surgeon indicated the bowel appeared to be adhered to the middle of the hernia graft and not to one of the tacks or sutures. The patient was released from the hospital a few days after the reoperation and is now reportedly doing well. The associated cook sales representative and the surgeon questioned if the biodesign hernia graft was possibly damaged in the attempts to insert the graft through the laparoscopic port, could that disrupt the surface of the graft and potentially increase the risk of adhesions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2016-00045 |
| MDR Report Key | 5567479 |
| Date Received | 2016-04-11 |
| Date of Report | 2016-04-06 |
| Date of Event | 2016-03-16 |
| Date Mfgr Received | 2016-04-05 |
| Device Manufacturer Date | 2015-10-02 |
| Date Added to Maude | 2016-04-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PERRY GUINN |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIODESIGN HERNIA GRAFT |
| Generic Name | HERNIA GRAFT |
| Product Code | OXK |
| Date Received | 2016-04-11 |
| Catalog Number | C-SLH-8H-13X22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | 1425 INNOVATION PLACE WEST LAFAYETTE IN 47906 US 47906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-04-11 |