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

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

Patient Problems Death (1802); Thrombosis (2100); Embolism/Embolus (4438)

Event Date 08/01/2015

Event Type  Death  

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, thromboembolic episodes, neurological deficits including stroke, peripheral thromboembolic events, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

During its post-market surveillance activities on 17-dec-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 procedure, an intraoperative thromboembolic complication occurred in which an occlusion of the m2 and m3 segments of the middle cerebral artery (mca) caused a parenchymal defect.Following the administration of 4000 units of intravenous heparin, the degree of occlusion improved.However, another parenchymal defect caused by an occlusion in the right a2 segment of the anterior cerebral artery (aca) was discovered in the post-operative setting.Post-procedure, the patient began to decline neurologically and expired two days post-procedure.There was no reported procedural complication with a smart coil.It should be noted that it is unclear if a smart coil was being used when the thromboembolic complication occurred and the cause of death was not specified.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: 11178094
• MDR Text Key: 227048602
• Report Number: 3005168196-2021-00096
• 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

• 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
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death