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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

During its post-market surveillance activities on 03-may-2022, penumbra inc.Became aware of a journal article titled, "endovascular treatment of medium and large intracranial aneurysms with large volume coils: a single center experience" (saal-zapata et al.2022).In this single center retrospective review, thirty-three patients with ruptured and unruptured intracranial aneurysms were treated between november 2017 and september 2019 using penumbra coil 400s (pc400s), a penumbra coil detachment handle (handle), a px slim delivery microcatheter (px slim), a neuron max 6f 088 long sheath (neuron max) and a guidewire (0.014¿).One patient who underwent a stent-assisted coiling (sac) procedure to treat an unruptured paraclinoid aneurysm using pc400s experienced an intraprocedural coil protrusion into the parent artery.Stent placement was required in order to avoid parent artery occlusion.It was not possible to ascertain specific device information from the article, nor to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14525483
• MDR Text Key: 294798117
• Report Number: 3005168196-2022-00235
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/03/2022
• 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: 36 YR
• Patient Sex: Female