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

Model Number 400SMTXSFT0102

Device Problems Physical Resistance/Sticking (4012); Premature Separation (4045)

Patient Problem Ischemia Stroke (4418)

Event Date 12/01/2021

Event Type  Injury  

Event Description

The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) using penumbra smart coil (smart coil), a penumbra smart coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician placed and detached a smart coil in the target location using the handle.The physician then advanced another smart coil into the target location and attempted to detach it using the handle; however, the smart coil failed to detach.While retracting the smart coil, the physician encountered resistance and the smart coil unintentionally detached partially in the microcatheter and partially in the target vessel.The physician then tried to push the smart coil into the target location using the pusher assembly.It was reported that part of the coil was left in the parent vessel.Subsequently, the physician used a stent device to push the remaining smart coil against the vessel wall.The procedure ended at this point.It was reported that the patient had an ischemic stroke with a possible relation to the smart coil.

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.Potential adverse events in the labeling with the penumbra smart coil system include, but are not limited to, aneurysm rupture, emboli, embolic stroke and other cerebral ischemic events, neurological deficits including stroke, ischemia, including death.Therefore, it was determined that the reported adverse event was an anticipated complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 13082732
• MDR Text Key: 285538038
• Report Number: 3005168196-2021-02796
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015187
• UDI-Public: 00814548015187
• Combination Product (y/n): N
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/23/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 400SMTXSFT0102
• Device Catalogue Number: 400SMTXSFT0102
• Device Lot Number: F107137
• 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: 12/01/2021
• Initial Date FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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: 64 YR
• Patient Sex: Male