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

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/01/2015

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the penumbra smart coil system include, but are not limited to hematoma or hemorrhage at access site of entry, coil herniation into parent vessel, intercranial hemorrhage , vessel spasm, thrombosis, dissection, or perforation.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

During its post-market surveillance activities on (b)(6) 2020, penumbra inc.Became aware of a journal article titled, "long-term follow-up results of the smart coil in the endovascular treatment of intracranial aneurysms." (mcavoy et al.2020).This article reports a single center prospective analysis of one hundred and five patients undergoing a total of one hundred and six procedures utilizing at least one penumbra smart coil (smart coil) between august 2015 and july 2018.During one stent-assisted embolization procedure on an unruptured aneurysm in the left anterior cerebral artery (aca), it was reported that a coil was extruding from the wall of an aneurysm in the junction of the a1 and a2 segments.Hemostasis was achieved with continued coiling and administration of protamine and the patient was discharged home on post-operative day 2.It should be noted that it is unclear what type of coil was being used when the issue occurred.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints.

• Brand Name: PENUMBRA SMART COIL
• 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: 11181607
• MDR Text Key: 228403337
• Report Number: 3005168196-2021-00104
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/17/2020
• 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