MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC PRESIDIO - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number UNKPRESIDIO

Device Problem No Apparent Adverse Event (3189)

Patient Problem Edema (1820)

Event Date 10/04/2010

Event Type  Injury  

Event Description

Headache leading to hospitalization.Investigator indicated mild severity; possibly related to micrus coils.Patient was enrolled on (b)(6) 2010.Pre-op modified rankin score was 0.The subject received coiling treatment for a large; incidental; unruptured basal artery aneurysm on (b)(6) 2010.The irregular 22 mm x 12 mm x 6 mm (neck) aneurysm was treated with 19 cerecyte coils.The post-op angiographic grading scale was 1; no filling of neck or dome.The patient was discharged on (b)(6) 2010 with an mrs score of 0.On (b)(6) 2010; the patient presented to er complaining of a headache.A ct taken on same day showed cerebral edema in the area of the coiling and patient was admitted.The patient was given darvocet for the headache; no medical treatment for the cerebral edema was given.The patient was discharged on (b)(6) 2010.At one month follow-up on (b)(6) 2010; the mrs score was 1.No diagnostic exams were performed.The subject returned on (b)(6) 2011 for a 6 month follow up.The angiogram showed a recurrence with the angiographic grading score was 2; filling of aneurysm neck but not dome.No retreatment was performed.Cerecyte coils used: (1) presidio 18; 18 x 20; (2) presidio 18; 18 x 46; (3) presidio 18; 16 x 47; (4) presidio 18; 14 x 47; (5) presidio 18; 10 x 34; (6) presidio 18; 10 x 34; (7) presidio 18; 8 x 30; (8) presidio 18; 8 x30; (9) micrusphere 18; 7 x 14.3; (10) cashmere 14; 6 x 15; (11) cashmere 14; 6 x 15; (12) cashmere 14; 5 x 12; (13) cashmere 14; 5 x 12; (14) cashmere 14; 4 x 8; (15) cashmere 14; 4 x 8; (16) deltaplush 10; 4 x 8; (17) deltaplush 10; 3 x 6; (18) cashmere 14; 2 x 2.5; (19) cashmere 14; 2 x 2.5.

Manufacturer Narrative

Concomitant medical products and therapy dates: (1) presidio 18; 18 x 20; (2) presidio 18; 18 x 46; (3) presidio 18; 16 x 47; (4) presidio 18; 14 x 47; (5) presidio 18; 10 x 34; (6) presidio 18; 10 x 34; (7) presidio 18; 8 x 30; (8) presidio 18; 8 x30; (9) micrusphere 18; 7 x 14.3; (10) cashmere 14; 6 x 15; (11) cashmere 14; 6 x 15; (12) cashmere 14; 5 x 12; (13) cashmere 14; 5 x 12; (14) cashmere 14; 4 x 8; (15) cashmere 14; 4 x 8; (16) deltaplush 10; 4 x 8; (17) deltaplush 10; 3 x 6; (18) cashmere 14; 2 x 2.5; (19) cashmere 14; 2 x 2.5 - details all unknown.Conclusion: headache leading to hospitalization.Investigator indicated mild severity; possibly related to micrus coils.Patient was enrolled on (b)(6) 2010.Pre-op modified rankin score was 0.The subject received coiling treatment for a large; incidental; unruptured basal artery aneurysm on (b)(6) 2010.The irregular 22 mm x 12 mm x 6 mm (neck) aneurysm was treated with 19 cerecyte coils.The post-op angiographic grading scale was 1; no filling of neck or dome.The patient was discharged on (b)(6) 2010 with an mrs score of 0.On (b)(6) 2010; the patient presented to er complaining of a headache.A ct taken on same day showed cerebral edema in the area of the coiling and patient was admitted.The patient was given darvocet for the headache; no medical treatment for the cerebral edema was given.The patient was discharged on (b)(6) 2010.At one month follow-up on (b)(6) 2010; the mrs score was 1.No diagnostic exams were performed.The subject returned on (b)(6) 2011 for a 6 month follow up.The angiogram showed a recurrence with the angiographic grading score was 2; filling of aneurysm neck but not dome.No retreatment was performed.Cerecyte coils used: (1) presidio 18; 18 x 20; (2) presidio 18; 18 x 46; (3) presidio 18; 16 x 47; (4) presidio 18; 14 x 47; (5) presidio 18; 10 x 34; (6) presidio 18; 10 x 34; (7) presidio 18; 8 x 30; (8) presidio 18; 8 x30; (9) micrusphere 18; 7 x 14.3; (10) cashmere 14; 6 x 15; (11) cashmere 14; 6 x 15; (12) cashmere 14; 5 x 12; (13) cashmere 14; 5 x 12; (14) cashmere 14; 4 x 8; (15) cashmere 14; 4 x 8; (16) deltaplush 10; 4 x 8; (17) deltaplush 10; 3 x 6; (18) cashmere 14; 2 x 2.5; (19) cashmere 14; 2 x 2.5.The products remain implanted and were not returned for evaluation.No corrective actions will be taken at this time.This mdr is being submitted as part of a retrospective review as the result of a recent fda audit and with accordance to the requirements of code of federal regulations.

• Brand Name: PRESIDIO - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4087459
• MDR Text Key: 17996791
• Report Number: 1226348-2014-00633
• 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,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/01/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKPRESIDIO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR