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Model Number MSPL1015 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Seroma (2069); Obstruction/Occlusion (2422)
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Event Date 11/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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This mdr is being submitted due to the reported occurrence of adhesions and bowel obstruction three months after the initial placement of the acell device.Upon further discussions with the explanting surgeon on 4/10/2018, it was determined that the patient developed a seroma shortly post operatively requiring drainage, and it was felt that the presence of the obstruction may have been caused not only by the recurrent adenocarcinoma, but also due to the implantation of the device during the hernia repair.The acell device may have led to the formation of adhesions to the surgical closure; which caused the development of the bowel obstruction, that necessitated operative intervention and partial device explantation.The explanted device was evaluated by hospital pathologist which revealed the presence of adherent omentum containing recurrent adenocarcinoma.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with fda, state, local, and acell's operating procedures.There were no reports of device failure at the time of initial surgery.
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Event Description
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Patient had a ventral hernia repair surgery conducted on (b)(6) 2017.An exploratory laporatomy on (b)(6) 2017 revealed the patient had multiple adhesions and multiple loops of small bowel stuck together with an acell surgical sheet.The adhesions were removed, the bowel resected and the acell surgical sheet was partially explanted.Hospital pathology results indicated the presence of adenocarcinoma in mesenteric tissue a follow up ct discovered diffuse adenocarcinoma throughout the bowel.The surgeon at the time believed that the complications were due to the spread of cancer post-operatively, not due to the acell surgical sheet.On 4/10/2018 acell received notification during a follow-up call between chief science officer and surgeon, it was discovered that patient developed a seroma post operative which was drained percutaneously.Additionally, it was the surgeon's opinion the diffuse cancer was the primary reason for adhesion formation.The development of adhesions to the surgical closure, which included an acell surgical sheet, may have led to the development of the bowel obstruction discovered on (b)(6) 2017, which necessitated operative intervention.It was this clarification on (b)(6) 2018 that prompted the reconsideration of this event from customer feedback based upon the primary reason for the complication being cancer, to reportable based upon the potential involvement of the device in the development of the bowel obstruction.
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Search Alerts/Recalls
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