MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC; TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS

Catalog Number UNK-CNV_NBCA

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

Patient Problems Stroke/CVA (1770); Hydrocephalus (3272)

Event Date 05/06/2015

Event Type  Injury  

Manufacturer Narrative

This is one of one initial/final mdr report being submitted for this complaint.Udi: unknown part number, all 3 attempts to obtain product were unsuccessful, udi is unavailable.Concomitant products: 5 fr envoy catheter (codman); 1.2 fr magic microcatheter (balt extrusion, (b)(4)).Mascitelli j.R , mcneill i.T., mocco j.,berenstein a., demattia j., fifi j.T.(2015, may 06); ruptured distal aica pseudoaneurysm presenting years after vestibular schwannoma resection and radiation; j neurointervent surg 2016;8:e19.(b)(4).The product was not available for analysis.A device history record (dhr) review could not be conducted as the lot number was not provided/known.Stroke and neurologic deficits, in this case specifically; hydrocephalus, are known potential adverse events associated with the use of the nbca trufill product and are listed in the ifu as such.Although there is not product specific information available, all products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.Review of the available information suggests that underlying disease process and target lesion anatomical characteristics may have contributed to the reported events.

Event Description

In the literature article ¿ruptured distal aica pseudoaneurysm presenting years after vestibular schwannoma resection and radiation.By justin r mascitelli, ian t mcneill, j mocco, alejandro berenstein, joseph demattia, johanna t fifi.Published: j neurointervent surg 2016;8:e19., it was reported that the patient presented with a hunt¿hess grade ii subarachnoid hemorrhage (sah) which was treated with endovascular parent vessel occlusion(pvo) using truefill nbca.Given that the pseudoaneurysm arose distal to brainstem perforators and there was a well sized right-sided posterior inferior cerebellar artery (pica) and superior cerebellar artery (sca), the decision was made to perform a pvo of the rostral branch of the right anterior inferior cerebellar artery (aica) at the level of the pseudoaneurysm using trufill nbca (codman neurovascular).Control angiography following the pvo demonstrated complete obliteration of the pseudoaneurysm as well as patency of the proximal portion and caudal branch of the anterior inferior cerebellar artery.The patient tolerated the procedure well and woke without any new neurological deficits.Over the following 24¿48 h, he developed worsening headache and communicating hydrocephalus, requiring placement of a right frontal external ventricular drain.A follow-up ct head 10 days after intervention demonstrated, a right cerebellar and brachium pontis stroke.The patient did not undergo mri.He ultimately required placement of a right frontal ventriculo-paritoneal shunt.He had a short stay in acute rehabilitation and is now doing well at home.At the time of complaint entry, no device specific information, i.E.Catalogue/lot number, is available.

• Type of Device: TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; 325 paramount dr; raynham, MA 02767 ; 5088288374
• MDR Report Key: 5768572
• MDR Text Key: 48717323
• Report Number: 1226348-2016-00114
• Device Sequence Number: 1
• Product Code: KGG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CNV_NBCA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR