MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNK LIQUID EMBOLIC; TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS

Catalog Number UNK LIQUID EMBOLIC

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

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Thromboembolism (2654)

Event Date 03/26/2013

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: bowman j, johnson j, mckusick m, gloviczki p, driscoll d.Outcomes of sclerotherapy and embolization for arteriovenous and venous malformations.Semin vasc surg.2013 mar;26(1):48-54.Doi: 10.1053/j.Semvascsurg.2013.04.001.Pmid: 23932562.Objective and methods: vascular malformations result from an arrest of development of a normal vascular structure or from abnormal growth of a vascular structure.Treatment continues to be a challenge.The purpose of this article was to study the outcomes of sclerotherapy and embolization for vascular malformations.The authors studied the clinical data of 60 patients treated with sclerotherapy or embolization for arteriovenous or venous malformations between 2006 and 2010 at mayo clinic.Follow-up information was obtained from clinical charts and a questionnaire sent to all patients.Overall, 60 patients (24 male and 36 female; mean age 31.7 years; range, 5.6 to 72.4 years) had 163 unique sclerotherapy or embolization procedures for lesions involving the lower extremity (55%), upper extremity (18.3%), pelvis (11.7%), abdomen (5%), chest (5%), back (3.3%), and multiple locations (1.7%).Thirty-one patients had low-flow venous malformations and 29 patients had high-flow arteriovenous malformations.There was no significant difference in complication rates or lesion size between patients with low-flow or high-flow lesions.There were no procedural deaths.Mean available follow-up was 2.0 ± 1.3 years (range, 0.5 to 5.0 years).Median pain scores at most recent follow-up decreased significantly (p<.001).Eighty-three percent of the responders (24 of 29) would recommend treatment to others.That authors concluded that with appropriate patient selection, sclerotherapy and embolization can decrease the pain of patients with arteriovenous and venous malformations.Multiple interventions might be necessary.Of note: the authors utilized embolization devices from several manufacturers but did not provide information to associate the following adverse events with specific device manufacturers.The actual number of cnv devices associated with these events is unknown.This complaint will capture all adverse events potentially associated with cnv devices.Any adverse events associated with competitor or unknown products or attributed to the patient¿s preexisting conditions will be excluded.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: n-butyl cyanoacrylate (trufill system, cnv).Other cerenovus devices that were also used in this study: non-cerenovus devices that were also used in this study: 95% ethanol, 3% sotradecol embolic [bionichepharma].Ivalon particles [contour; target vascular/boston scientific].Bead block particles [bead block; biocompatibles].Ethanolamine [reed & carnrick].Unk coils.Onyx [covidien].Adverse event(s) and provided interventions associated with cerenovus devices: 3 reports of unspecified symptomatic nerve damage- treatment unknown.1 report of thrombus, location of and treatment for the thrombus is unknown.1 report of unspecified infection- treatment unknown.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Bowman j, johnson j, mckusick m, gloviczki p, driscoll d.Outcomes of sclerotherapy and embolization for arteriovenous and venous malformations.Semin vasc surg.2013 mar;26(1):48-54.Doi: 10.1053/j.Semvascsurg.2013.04.001.Pmid: 23932562.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.(b)(6).The initial reporter phone is not available.The device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.Since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: UNK LIQUID EMBOLIC
• Type of Device: TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 12619601
• MDR Text Key: 283689473
• Report Number: 1226348-2021-00097
• Device Sequence Number: 1
• Product Code: KGG
• Combination Product (y/n): N
• PMA/PMN Number: P990040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LIQUID EMBOLIC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BEAD BLOCK¿ (BIOCOMPATIBLES-BOSTON SCIENTIFIC); CONTOUR¿ PVA PARTICLES (BOSTON SCIENTIFIC); ETHANOLAMINE [REED & CARNRICK]; ONYX [COVIDIEN]; SOTRADECOL (BIONICHE PHARMA); UNK COILS
• Patient Outcome(s): Other