Catalog Number HIAT0706 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Gastritis (1874); Vomiting (2144); Decreased Appetite (4569)
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Event Type
Injury
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Event Description
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It was reported that the patient experienced complications after a surgery on (b)(6) 2020 to repair an hiatal hernia, with the repair being reinforced with a gentrix surgical matrix device.A (b)(6) female patient had lack of appetite, weight loss, vomiting, gastritis, esophagitis, dysphagia, and gerd before the surgery.The patient experienced the same preoperative symptoms in the postoperative plus a loose valve between the distal end of the esophagus and the point of attachment to the stomach, incisional pain and steroid injections.The patient medical history indicated that at 9 months old she had a g-tube surgically placed and remained in place until the age of 5 years old.It is unclear how many esophogoscopies or surgeries she had between ages 5 until 25 when she had the nissen fundoplication performed with the acell device.Moreover, the patient stated that the procedural notes from the scope procedure indicate everything is fine, yet the operative notes describe anatomical and surgical defects in which it does not address her post-op symptomology.No other information has been provided.
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Manufacturer Narrative
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(b)(4).An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Manufacturer Narrative
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The gentrix hiatal matrix (hiat0706) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The main reason for the hernia complications post device implantation is not known.As per hazard analysis, safety characteristics, the devices are expected to resorb over time concurrent with the host tissue deposition.No attempt to explant the device was made.Furthermore, the device would be fully resorbed this long following implantation back on (b)(6) 2020.Finally, post-operative symptomology being similar to pre-operative symptomology is not uncommon following nissen fundoplication.
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Event Description
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N/a.
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Search Alerts/Recalls
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