MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC UNK LIQUID EMBOLIC

Catalog Number UNK LIQUID EMBOLIC

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Ruptured Aneurysm (4436)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4)."literature article ¿multimodal cerebral arteriovenous malformation treatment: a 12-year experience and comparison of key outcomes to aruba¿ reviewed.Pulli b, chapman ph, ogilvy cs, patel ab, stapleton cj, leslie-mazwi tm, hirsch ja, carter bs, rabinov jd.J neurosurg.2019 nov 1:1-10.Doi: 10.3171/2019.8.Jns19998.Epub ahead of print.Pmid: 31675689.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

"literature article ¿multimodal cerebral arteriovenous malformation treatment: a 12-year experience and comparison of key outcomes to aruba¿ reviewed.Pulli b, chapman ph, ogilvy cs, patel ab, stapleton cj, leslie-mazwi tm, hirsch ja, carter bs, rabinov jd.J neurosurg.2019 nov 1:1-10.Doi: 10.3171/2019.8.Jns19998.Epub ahead of print.Pmid: 31675689.Objective: curative treatment of unruptured brain arteriovenous malformations (avms) remains controversial after the only randomized controlled trial, a randomized trial of unruptured brain arteriovenous malformations (aruba), was halted prematurely because interim analysis revealed superiority of the medical management group.In contrast, meta-analyses of retrospective cohorts suggest that intervention is much safer than was found in aruba.Methods the authors retrospectively analyzed 318 consecutive adult patients with brain avms treated at their institution with embolization, surgery, and/or proton beam radiosurgery.Analysis was performed in 142 aruba-eligible patients (baseline modified rankin scale [mrs] score 0¿1, no history of hemorrhage), and results were compared to primary and secondary outcomes from aruba, as well as to natural history cohorts.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: trufill n-butyl cyanoacrylate (codman) other cerenovus devices that were also used in this study: n/a non-cerenovus devices that were also used in this study: onyx (medtronic), stereotactic bragg peak, proton beam therapy adverse event(s) and provided interventions: (1) intraprocedural cavm rupture (1) postoperative hemorrhage requiring repeat craniotomy and hematoma evacuation (2) stroke (either ischemic or hemorrhagic) (1) death was attributed to embolization (intraprocedural avm rupture that required emergency craniotomy for clot evacuation).

• Brand Name: UNK LIQUID EMBOLIC
• Type of Device: LIQUID EMBOLIC
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 12571803
• MDR Text Key: 282045855
• Report Number: 1226348-2021-00075
• 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: health professional,literatur
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• 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: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ONYX MEDTRONIC; STEREOTACTIC BRAGG PEAK, PROTON BEAM THERAPY
• Patient Outcome(s): Life Threatening