MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM REPERFUSION CATHETER 032; NRY

Catalog Number PSC032

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

Patient Problem Reocclusion (1985)

Event Date 03/21/2011

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure using the penumbra system reperfusion catheter 054/032 and separator 054/032.During the procedure, a reperfusion catheter 054 was used over a reperfusion catheter 032 and a transend microwire (200cm).After the wire and reperfusion catheter 032 were advanced mid lacerum, they were removed and aspiration with the reperfusion catheter 054 was performed for about 15 minutes.A follow up angiogram demonstrated there was no filling defect in the internal carotid artery (ica) but also demonstrated a "cut off at the distal ipsilateral a2 branch." then, the procedure to recanalize the right mca vessel commenced.The reperfusion catheter 054 was advanced into the right middle cerebral artery (mca) and aspiration ran for about 25 minutes.Just after, an angiogram was performed and demonstrated partial recanalization of the m1, distal slow antegrade flow into the inferior division of the mca.A follow-up angiogram taken minutes later demonstrated complete re-occlusion of the mca.To treat the re-occlusion of the m1, the treating physician used a prowler plus select catheter, advancing it over a transend microwire into the m1 segment.The microwire was removed and an enterprise stent (4.5 x 37mm) was utilized as a "stentreiver".The angiogram then showed significant recanalization, however a few minutes later, the vessel again re-occluded.To treat the second re-occlusion of the m1, an apex balloon (2 x 15mm) was used to perform a balloon angioplasty, yielding some improvement of blood flow.Then a vision stent (2 x 8mm) was deployed in the m1 segment with further restoration of flow to the distal portion of the mca.Finally, the physician moved forward with treating the right a2 clot.A gateway balloon (2 x 15mm) was used to conduct an angioplasty.An apex balloon (2 x 15mm) was used soon after, which allowed for some restoration to the blood flow.The final angiogram demonstrated significant improvement of flow in both the mca and aca territories.No further issues were detected and no device malfunctions occurred during the procedure.The relationship between the device and the event are definite with moderate in severity.

Manufacturer Narrative

Conclusion: re-occlusion (distal embolization) is a known and anticipated complication with these types of procedures and is noted in the device labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.This mdr is associated with mdr 3005168196-2014-00287, 00289 and 00290.Device was disposed of by the hospital.

• Brand Name: PENUMBRA SYSTEM REPERFUSION CATHETER 032
• Type of Device: NRY
• 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: 3803525
• MDR Text Key: 4386701
• Report Number: 3005168196-2014-00288
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: PSC032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 80 YR