MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number UNKPRESIDIO

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2013

Event Type  malfunction  

Manufacturer Narrative

Procode: krd/hcg.Udi: unknown part number, attempts to obtain product part number were unsuccessful, udi unavailable.Date of event, product code, and lot number not available.Three attempts to obtain additional information from the author were unsuccessful.This is an initial/final mdr report.Article attached to this mdr: reeves, e.R., babak, s., jahromi, s.Et al.(2013).Coil embolization of a coronary artery to left ventricular fistula using detachable coils.Catheterization and cardiovascular interventions 82:155¿158 (2013).Conclusion: the device was not available for analysis.In addition, the lot number was not provided; therefore, a dhr could not be performed.Coil protrusion into parent vessel is a known procedural complication related to coil implantation.The root cause of this event could not be definitively determined; however, based on the information provided, it appears that the off-label use of the presidio coils in a coronary fistula with a neck too narrow to contain the coils may have contributed to the event.Per the instructions for use, ¿the microcoil delivery system is intended for endovascular embolization of intracranial aneurysms.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is 1 of 2 mdr reports being submitted for the literature article, with report numbers of 2954740-2017-00141 and 2954740-2017-00140.

Event Description

In the literature article ¿coil embolization of a coronary artery to left ventricular fistula using detachable coils¿ by e.Rodney reeves, md, babak s.Jahromi, md, and frederick s.Ling, md, published catheterization and cardiovascular interventions 82:155¿158 (2013), it was reported that during placement two presidio coils (catalog and lot numbers not included in article)prolapsed from the target aneurysm and were not implanted.Per the article, a (b)(6) woman had experienced four months of progressive exertional dyspnea and angina that evolved to nyha class ii heart failure and ccs class iii angina.Ct angiogram was performed which revealed that a separate lad and rca fistula appeared to join together with the confluence of the two draining into the left ventricle.The rca was negotiated with a choice pt wire (boston scientific, natick, ma) and placed in the common fistula.A telescoping microguide system was then advanced over the choice pt wire consisting of a dac distal access catheter (concentric medical, mountain view, ca) through which an echelon microcatheter (ev3 neurovascular, irvine, ca) was advanced into the common fistula from the lad pda and rca.Failed attempts were made to place either a 20 cm x 50 mm presidio-18 cerecyte coil or a 12 cm x 40 mm presidio coil into the common fistula.The attempts failed due to the lack of a narrow enough neck within the common portion of the fistula to contain the coil loops.Despite multiple attempts, the coil loops would prolapse into the left ventricle, and thus these coils were not detached and were removed.It was decided to separately coil the lib of the lad pda fistula into the common fistula, followed by the limb of the rca fistula into the common fistula.Following implantation of multiple coils, coronary blood flow in bot he rca and lad appeared to be reduced, as the low resistance fistulas were now closed.She remained chest pain free and was ambulating without difficulty the following morning, and was discharged home.

• Brand Name: PRESIDIO - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6646464
• MDR Text Key: 77932330
• Report Number: 2954740-2017-00140
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKPRESIDIO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/16/2017
• 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 Age: 58 YR