MAUDE Adverse Event Report: UNKNOWN STRATTICE MESH, SURGICAL

Catalog Number UNK STRATTICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735)

Event Type  Injury  

Event Description

During a literature view performed by patient safety operations on 8/3/2021, an article titled "a comparative study of autologous and acellular dermal matrix static cheek slings in corrective surgery for facial palsy" was identified and reported a retrospective review of consecutive patients who underwent cheek sling surgery for facial palsy over a 5-year period (2014¿2018) in a tertiary facial palsy center. The study group comprised 41 patients on which 33 autogenous fascia lata slings and 12 strattice slings were performed. The mean age at surgery was 63. 95 years and 61% were male. Comorbidities included smoking, hypertension, diabetes, and autoimmune diseases. Facial palsy etiology was diverse but parotid tumors, acoustic neuroma surgery, and squamous cell carcinomas were the most common causes. Thirty-three patients had preexisting facial weakness before surgery. At the time of the sling placement, 6 patients presented with a partial facial palsy, whereas the rest of the patients experienced a total paralysis either before the procedure or immediate due to resection of the facial nerve during the same surgery. In 11 cases, the sling was placed immediately or up to 2 months from the onset of the paralysis. Within the total cohort of 41, 6 patients received radiotherapy before the procedure and 14 afterward. Within the total number of procedures, we performed 33 tfl slings (73. 3%) and 12 strattice slings (26. 7%). The majority of the slings placed (41 slings, 91. 1%) were performed with simultaneous ancillary procedures (table 1). The mean follow-up time was 38. 02 ± 19. 17 months (range, 4¿72). Twelve (29. 3%) of 41 patients were deceased at the end of study period underlining the advancing age, comorbidity, and prevalence of aggressive tumors in this group. Complications occurred in 15 slings, most were mild local infection, wound dehiscence, donor site seromas, sling stretching, and facial hematoma. There were no reported donor site infections or significant thigh numbness except when alt was harvested simultaneously. Stretching occurred in 4 tfl slings and 5 strattice slings. Of the 9 patients with documented significant stretching of the sling, 4 (2 strattice, 2 tfl) underwent a further sling procedure at a mean time of 20 months (range 8¿30). Two further patients required surgical reoperation (hematoma and wound dehiscence). No statistical difference in complication or stretching rate was observed with the following risk factors: age, sex, arterial hypertension, diabetes mellitus, autoimmune disease, facial palsy etiology, time of the sling procedure regarding facial palsy onset, sling material, ancillary procedures in the same surgery, and radiotherapy (table 2). Smoking and partial palsy increased the risk of complications (p
=
0. 039, p
=
0. 032, respectively). A higher tendency for stretching requiring revision among the strattice slings was observed but did not achieve significance (p
=
0. 087) at follow-up. The overall conclusion stated that fascia lata and strattice slings provide satisfactory results in restoring symmetry at rest and functional oral competence. Their results suggest that strattice is a safe sling material with an acceptable risk profile and comparable medium-term maintenance of tensile strength to fascia lata, and should be considered where life expectancy, donor site morbidity, and procedure length are important considerations. Based on the reported information, this would be considered off-label use since the strattice was used to treat a condition caused by nerve injury rather than a soft tissue defect.

Manufacturer Narrative

Initial reporter: corresponding author and institution. This literature review is being reported as an individual event type as serious injury due to the surgical intervention for the reported wound dehiscence and assumed medical intervention to treat the minor local infection complication. It is unclear from the information in the publication whether the hematoma event occurred in any of the strattice patients and although serious injury was reported; hematoma is considered a procedural complication and not device related. It is unknown if the strattice devices were explanted. It should be noted that the use of strattice as a static sling to treat facial palsy is considered off-label use. Multiple attempts are being made to contact the corresponding author to gather additional patient and procedure specific information including lot numbers and device dispositions. To date, the lot numbers associated with these events remain unknown; therefore an internal investigation into the device history records could not be performed. Based on the reported information, a relationship between the events and the strattice devices cannot be determined. No further actions are required as a nonconformance could not be confirmed. If additional information is received, a supplemental report will be submitted.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• MDR Report Key: 12388220
• MDR Text Key: 280585640
• Report Number: 1000306051-2021-03048
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 08/30/2021 Patient Sequence Number: 1

Treatment

NO INFORMATION