MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number 4004C1020

Device Problem Detachment Of Device Component (1104)

Patient Problems Stroke/CVA (1770); Thrombus (2101); Dysphasia (2195)

Event Date 03/30/2014

Event Type  Injury  

Event Description

The patient was undergoing an embolization procedure using the penumbra coil 400 system.During the procedure, the first coil was being deployed into the aneurysm when the distal end of the coil herniated into the parent vessel and was carried with blood flow from the ica to the aca.At this point, the coil was still attached to the pusher assembly and the physician attempted to pull the coil back into the catheter to reposition it inside the aneurysm.However, upon retraction into the microcatheter, the coil detached and was eventually retrieved with a retrieval device and the coil was removed without further an issue.Subsequent coils were deployed without incident until deployment of a 4mm x 12cm complex soft coil.Several coil loops herniated into the parent vessel and the first recovery attempt failed, in which the coil also detached prematurely and was carried by blood flow into the proximal middle cerebral artery (m1 segment).Subsequent recovery attempts were made, during which blood flow distal to the coil slowly reduced and the patient displayed onset of stroke symptoms due to thrombus formation.After multiple retrieval attempts, both coil and thrombus were retrieved by a solitaire stent retriever and achieved flow restoration.The procedure concluded without further incident, though the patient did have new left-sided weakness, facial droops, and difficulty with speech.

Manufacturer Narrative

Conclusion: the product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This mdr is associated with mdr 3005168196-2014-00256.Device was disposed of by the hospital.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 3782511
• MDR Text Key: 4377936
• Report Number: 3005168196-2014-00255
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• 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: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 4004C1020
• Device Lot Number: F39844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 47 YR