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

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

Patient Problem Thromboembolism (2654)

Event Date 02/22/2022

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, peripheral thromboembolic events, vessel spasm, thrombosis, dissection or perforation, thromboembolic episodes, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

The patient was undergoing a coil embolization procedure to treat a ruptured bifurcation aneurysm in the anterior cerebral artery (aca)-anterior communicating artery (acom) using penumbra smart coils (smart coil) and a non-penumbra microcatheter.During the procedure, a smart coil would not advance into the microcatheter; therefore, the smart coil was removed.The physician then successfully placed four smart coils in the target location using the microcatheter.Afterwards, a control angiographic series was performed that indicated that there was a thrombus adjacent to a protruded loop towards a2 and small repletion defects in relation to thromboembolism in the callosomarginal artery.Subsequently, 15 ml of tirofiban intraarterial (ia) and 17 ml intravenous (iv) was administered to the patient, achieving resolution of the repletion defect.The thromboembolism was reported to be a serious adverse event with a probable relationship to the smart coil system and the index procedure.

• 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: 13847609
• MDR Text Key: 288807092
• Report Number: 3005168196-2022-00133
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• 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: 02/23/2022
• 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: 77 YR
• Patient Sex: Female