MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND MATRIX - UNSPECIFIED; N/A

Catalog Number XXX-SURGIMEND

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

Ps journal published (2017) "the comparison of strattice and surgimend in acellular dermal matrix¿assisted, implant-based immediate breast reconstruction." the aim of this study was to compare strattice and surgimend for postoperative clinical outcomes following immediate, implant-based breast reconstruction.Methods: the study, conducted across three hospitals, included all patients who underwent immediate implant-based breast reconstruction using strattice and surgimend.The primary outcome measure was implant loss rate.Secondary outcome measures included acellular dermal matrix loss rate, seroma formation, and minor and major complication rates.Intergroup comparison was performed.Strattice (porcine derivative) and surgimend (bovine derivative) are the two most common acellular dermal matrices used in breast reconstruction in the united kingdom.This retrospective study compared clinical outcomes in immediate implant-based breast reconstruction patients.Eighty-two patients (strattice, n = 45; surgimend, n = 37) underwent 97 immediate implant-based breast reconstructions (strattice, n = 54; surgimend, n = 43).Postoperative outcomes for surgimend: implants loss within 3 months - 3 (wound breakdown 1; infection 2).Local complications: postoperative complication - 21, seroma - 20 - (5 seromas drained), hematoma - 5, skin flap problems - 10, nipple-areola problems - 5, red breast - 9, other minor complications - 3.Infections outcomes: implant infection - 2, wound infection - 9, therapeutic antibiotics - 12, reoperation - 3 - reason for reoperation: removal of implant and washout (2); removal of implant, washout and insertion of expander (1).Results: there were no differences between groups for age, comorbidities, specimen weight, or implant volume.Drains were used in all strattice and 36 (84 percent) surgimend cases.The implant loss rate was higher for strattice compared with surgimend, but failed to reach statistical significance.The acellular dermal matrix loss rate was significantly higher in the strattice group, with no acellular dermal matrix loss with surgimend.The reoperation rate was also significantly higher in the strattice group.The incidence of red breast was significantly higher in the surgimend group.Seroma, wound problems, and infection rates were similar.Conclusions: clinical outcomes, including implant loss, acellular dermal matrix loss, and reoperation rates, are significantly better when using surgimend in immediate implant-based breast reconstruction compared with strattice.

Manufacturer Narrative

Root cause is indeterminable.No lot number was provided in the complaint documentation, therefore dhr review could not be conducted.The only information provided was the product name, surgimend.The device was not returned for failure analysis.

• Brand Name: SURGIMEND MATRIX - UNSPECIFIED
• Type of Device: N/A
• Manufacturer (Section D): TEI BIOSCIENCES INC; 7 elkins street; 7 elkins street; boston MA 02127
• MDR Report Key: 8212303
• MDR Text Key: 131916487
• Report Number: 3004170064-2019-00001
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K083898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-SURGIMEND
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1