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Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Necrosis (1971)
Event Type  Injury  
Event Description
During a literature review performed by medical safety, an article titled "shoulder-related donor site morbidity after delayed breast reconstruction with pedicled flaps from the back: an open label randomized controlled clinical trial" was identified that discussed the aim of the multicentre randomized clinical trial was to further investigate the differences in shoulder-related morbidity associated with delayed breast reconstruction by the two flaps, in order to establish whether there is sufficient evidence to support the hypothesis that tap flap-based re-constructions provide better postoperative shoulder function. The study was designed as a superiority trial with two parallel study-arms, as patients were allocated to breast reconstruction by either a ld or a tap flap in a ratio of 1:1. Patients were planned for enrolment in the two-year period between 1 september 2013 and 31 august 2015, or until a minimum of 50 participants were included. Inclusion criteria were all women over 18 years referred for unilateral,delayed breast reconstruction, who were found best suited for, and opted for, breast reconstruction with a pedicled flap from the back. Breast reconstruction with the tap flap requires a mesh to support the implant to reduce the risk of complications. To ensure uniformity, an adm (strattice) for all patients was used in the tap group. The article indicated this increases the procedural cost, but as more types of meshes emerge and prices develop this expense diminishes. Based on the above, the additional costs of applying the tap flap are acceptable. There were 21 women in the ld group and 23 women in the tap group received the allocated reconstruction and proceeded to follow-up. Before completion of the 12- months follow-up, one additional patient from each group left the trial and were lost to follow-up. A further two women from the ld group died due to recurrence of their cancer. This left 18 women in the ld group and 22 in the tap group, who completed the trial and were included in the modified itt population. Demographics and data for breast cancer treatment were comparable between the groups. Data related to the course of breast reconstruction, the following hospitalization and complication rates were also without statistically significant differences between the groups. Patients in the tap group listed age 55. 8 years, bmi 25. 4, current and former smokers, hypertension, and cancer. 17 patients had radiation, 15 had chemo. The complications listed in the tap group include 1 haematoma, 1 infection, 3 minor necrosis and 1 major necrosis. The article also lists 4 major complications and 2 minor complications. Major complication was defined as complications requiring surgical intervention where as minor complication was defined as complications treated conservatively. Minor necrosis was defined as epidermolysis and small necrosis of the most distal part of the flap. Major necrosis was defined as necrosis requiring removal of the implant. In the tap group, six patients experienced complications, four of which required surgical intervention (haematoma, major flap necrosis and minor flap necrosis). In the case of major necrosis, the flap was revised, and the implant was changed to an expander. There were no cases of failure. Data on patient-reported shoulder-related pain showed a significant difference at 12 months after surgery. When applying the logistic regressions model to adjust for pain at baseline, we found a significantly decreased risk of experiencing pain when reconstructed by the tap flap. The estimated effect on the total css at 12 months, when applying the tap flap instead of the ld flap and adjusting for differences in the baseline score, was 6. 2 points with 95%ci(0. 5¿12. 0), which was statistically significant. Furthermore, there was a statistically significant positive effect on the total css at six months after the reconstruction of 5. 6 points 95%ci(0. 1¿11. 0). The total css did not differ significantly at three months. The tap flap seems to have a statistically significant positive effect on pain and adl, while there is no significant effect on rom and strength after one year of follow-up. The same effect can be found at six months after the surgery, where strength also shows to be an aver- age of two points higher in the tap group. At three months, only adl shows a significant difference, with a higher score amongst the tap patients. The overall conclusion reported that the results of the study show a difference in shoulder-related donor site morbidity between the two flaps, demonstrating a clear advantage to the tap flap. Patient reconstructed by the tap flap are thus less likely to experience shoulder-related pain and have a better function of the shoulder one year after the reconstruction. The tap flap is thus superior to the ld flap as harvest of the latter carries a higher risk of shoulder function impairment, chronic pain and reduced adl. A longer follow-up period is needed to establish whether this difference change and perhaps becomes even more significant over time. Further investigation into differences in patient satisfaction and esthetic outcome of the two procedures is also warranted.
Manufacturer Narrative
Corresponding author and institution. This literature review is being reported as an individual event type as serious injury due to the reported complications with surgical intervention. Multiple attempts were made 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. No devices were returned to lifecell for evaluation. Based on the information reported, a relationship to the strattice could not be determined. No further actions are required, a nonconformance was not confirmed. If additional information is received, a supplemental report will be submitted.
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Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
MDR Report Key14570385
MDR Text Key294802041
Report Number1000306051-2022-00103
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/01/2022 Patient Sequence Number: 1