MAUDE Adverse Event Report: THERAKOS, INC THERAKOS XTS PHOTOPHERESIS SYSTEM

Lot Number NOT AVAILABLE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Missing Value Reason (3192)

Patient Problems Abdominal Pain (1685); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

System was used for treatment.A batch record review of a specific kit lot could not be performed as no lot number was provided in the article.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or noncoformances related to the complaint were noted.Trends were reviewed for all complaint categories and no trend was detected for allergic reaction (anaphylaxis).No corrective and preventive actions have been initiated for this complaint category.From a device perspective this event did not cause or contributed to a death or serious injury, and the system did not cause or contributed to a death or serious injury nor malfunction in a way that would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.There is no device malfunction and, therefore, not reportable as an mdr; 8-mop was used instead of uvadex.The operator's manual clearly states the use of uvadex with ecp only.The ae is possibly related to the reinfusion of 8-mop which was used during ecp procedure.The author was contacted for more information.However, no information about patient's health was known.This event happened during ecp procedure and medical intervention was necessary, therefore, this case is reportable as an adr.This case is serious, related to 8-mop and reportable from a drug perspective.(b)(4): device not available for analysis.

Event Description

Article found in scheduled literature search article title: treatment of acute graft-versus-host disease in childhood with extracorporeal photochemotherapy/photopheresis: the padova experience - journal: biology of blood and marrow transplantation, from website: journal homepage: www.Bbmt.Org, american society for blood and marrow transplantation (asbmt).Acute graft-versus-host disease (agvhd) is the major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation.Systemic steroid treatment represents the first-line therapy for agvhd and is associated with a response rate of 30% to 60%.Steroid-resistant patients have a poor prognosis with high transplantation-related mortality (trm).Several second-line therapies have been proposed for the management of unresponsive agvhd, without proven beneficial effects on patients' outcome or overall longterm survival.For these reasons, extracorporeal photochemotherapy/photopheresis (ecp), a cell-based approach to control gvhd that spares generalized immunosuppression, seems to be promising.In this study, we report the outcome of 72 consecutive pediatric patients treated with ecp between 1997 and 2013 for agvhd.Among them, 21 patients had steroid-resistant agvhd, 42 had steroid-dependent agvhd, and 9 did not receive steroid as first-line therapy because of clinical contraindications.A complete response was obtained in 72% of patients, a partial response was observed in 11%, and there was no response in 17% of patients.At day ޱ80, trm was 4% in the whole cohort; trm was 3% and 20% among responders and nonresponders to ecp, respectively (p <.0001).The 5-year overall survival was 71%, showing a difference between responders and nonresponders of 78% and 30%, respectively (p 1/4 0004).The 5-year time to progression of primary disease was 81%, without any significant difference between the 2 groups.Moreover, the 5-year progression-free survival of primary disease was 72%, with a significant difference (p 1/4 007) between responders (79%) and nonresponders (30%) to ecp.In conclusion, this study demonstrates that ecp is highly effective in agvhd without a negative impact on primary disease.Under complications "one girl, after 10 ecp procedures, had anaphylaxis (caught vomiting, abdominal pain, hypotension and palpebral edema) a few minutes after end of 8-mop irradiated bag infused.She responded to antihistamine and steroid therapy, but ecp treatment was stopped." update: 8/14/15 jb author was emailed offlince call capture form to get more information about ae.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5025066
• MDR Text Key: 23908107
• Report Number: 2523595-2015-00225
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Nurse

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention