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Mdr report# mw5147066 was received with the following information: "dr.(b)(6) enrolled plaintiff (b)(6) in the study, despite failing to recognize that he violated a preoperating exclusion condition of revision surgery at the same level of the spine.Appx.#13, pp.115 116; see appx.#6, pp.43 44, 54.Plaintiff (b)(6) had pre-existing instruments, her bone cages and connecting rods and screws.In one of their documents in the fda s pma file, confluent stated that the situation targeted by the exclusion is a tear in the dura mater (unintended or incidental) from the instruments (in plaintiff s case bone cages).(b)(6) surgery involved an intended tear to the dura mater to remove the intradural tumor.But her infection may have been caused by a leak from an untended durotomy from the bone cages, screws or rods touching the dura mater at a point other than dr.(b)(6) incision.As discussed, the endpoint of the clinical trial was solely a valsalva maneuver that involved pinching the dura mater to slightly increased pressure and observing solely the surgical incision for a leak of cerebrospinal fluid (csf).Appx.#6, pp.50 - 52.(b)(6) infection was very fluctuant on (b)(6) 2006, and dr.(b)(6) i & d performed on that date portended her failure to fuse the vertebrae with the bone cages.The failure of dr.(b)(6) surgery to fuse the hardware with the spinal column made dr.(b)(6) and delamarter s surgeries necessary.Dr.(b)(6) failed to perform a mri that confluent recommended in the fda documents in the pma file to rule out injury to the study subject caused by the duraseal.The surgeons that plaintiff (b)(6) will be consulting this time have had experience with the injuries; and they will know the bad tendencies of duraseal to cause injury in a case like (b)(6) case.The hospital staff almost certainly disposed of the first (shipped) duraseal kit in (b)(6) surgery that dr.(b)(6) opened and rejected, because dr.(b)(6) and the hospital staff found the applicator to be defective or too difficult to work.Dr.(b)(6) declaration is that he believes duraseal is an inferior product to adherus and he doesn't use it as of 2015.Appx.#4, pp.13 - 16.Dr.(b)(6) declaration is that he believes that duraseal is an unreliable, defective product and he doesn t use it as of 2015.Appx.#3, pp.9-12.The unsealed evidence in the patent law case was that surgeons preferred adherus to duraseal because the duraseal s applicator clogs and is ineffective, and the hydrogel is weak and tends to degrade easily and is weak.Appx.#3, pp.10 11.And also that there were complaints of the runoff of the expanding duraseal polymer to surrounding tissue and damage nerve roots in confined bony spaces.See ibid; see also email, appx.2, pp.7 - 8.Dr.(b)(6) and confluent violated many federal duties which are intended to assure data integrity for the subject s (b)(6) participation in the clinical study.These critical issues in her surgery that the duties of data integrity were intended to address, eg.The superexpansiveness of the spinal sealant actually used, the defective applicator and the risk of injury to nerve roots resulting therefrom, and the complaints of surgeons of infections caused by duraseal, were subjects that confluent and dr.(b)(6) could have included in the consent form and consent discussion under foreseeable risks.21 cfr 50.25 (a)(2,3) (2022).Plaintiff (b)(6) contends that the foreseeable risks to her safety outweighed the benefits to safety from ease of application of the duraseal, and under the law of medical battery dr.(b)(6) and confluent were obligated to discuss the risks to her safety and explain that these risks outweighed hypothetical benefits for her safety from a shorter surgery under duraseal as compared to standard of care methods.Trantafello v.Medical center of tarzana (1986) 182 cal.App.3d 315.Trantafello denied the extension of limitations period of medical malpractice under cal.Code civ.Proc.340.5 because of the express exception in that statute for a foreign body left in the patient during surgery.The foreign body had to be left inside the patient for the purpose of pure research, which the court of appeals defined as lacking all therapeutic purpose.The court of appeals held that the acrylic disc implant used on the patient had a therapeutic purpose despite that it was a class iii medical device not subject to (and therefore not approved in) clinical trials.Daley is remarkably similar to the facts of this case.It involved clinical trials for a novel treatment for twin-twin transfusion syndrome.The plaintiff alleged that the experimental open fetus laser ablation procedure that was performed on her placenta and uterus was different from the procedure consented to, which was percutaneous by needle.She signed a consent form to inclusion in the study, and the nih procedures were used to obtain consent.Daley alleged violations of the protocol and the consent form and hospital policy.".
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Duraseal xact 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 is undetermined and was unable to be confirmed in the complaint evaluation.A dhr review and trending were performed as part of the evaluation.Proper finished good testing is performed prior to release as indicated on each dhr.Product was not received for analysis and the investigation could not confirm the complaint.Per the afmea, potential causes of failure include: not following labeling, instructions for use.The risk remains acceptable per the risk analysis.No enhancements or improvements were generated for the reported condition.The complaint will be closed as could not be reliably determined.Should new information become available, the complaint will be re-opened and the investigation summary will be amended as appropriate.
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