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

Device Problem Unintended Movement (3026)

Patient Problem Thrombosis (2100)

Event Date 11/03/2017

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Potential adverse events in the labeling with the penumbra smart coil system include, but are not limited to, thrombosis, coil herniation into parent vessel, distal embolization, emboli, embolic stroke and other cerebral ischemic events, vessel spasm, dissection, or perforation, including death.Therefore, it was determined that the reported adverse event was an anticipated complication.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

On (b)(6) 2017, the patient underwent a coil embolization procedure in the posterior cerebral artery (pca) using penumbra smart coils (smart coils).During the procedure, a non-penumbra microcatheter was advanced through a catheter and a benchmark 6f 071 delivery catheter (benchmark).The smart coils were then placed into the target vessel.An initial angiogram through the microcatheter was performed and showed the smart coils protruded into the parent left p1 segment of the target vessel.In addition, a follow-up angiogram from the benchmark revealed an interval development of a clot on the left p1.A bolus of integrilin was then given, with some interval improvement in thrombosis, but there was no complete resolution.The physician decided to resume and attempt a thrombectomy procedure with aspiration, and the microcatheter and catheter were removed.A penumbra system 3max reperfusion catheter (3maxc) was advanced to the target vessel and used to engage the clot; aspiration was attempted.After the 3maxc was removed, another follow-up angiogram through the benchmark was performed and showed interval partial recanalization with distal flow in the target vessel and a proximal basilar dissection flap that was non-flow limiting with no adjacent thrombosis.The patient was given an integrilin infusion drip.Repeated interval angiograms were performed and showed stable findings.The clot formation in the target vessel was resolved on the same day, and the procedure ended at this point.The clot formation in the target vessel was reported to be a serious adverse event with a definite relationship to the index procedure and the smart coil system.

Manufacturer Narrative

Additional clarification received on (b)(6)-2020 indicated that this complaint was already reported under mfr report number 3005168196-2017-02105.Therefore, please disregard this duplicate report.This report is associated with mfr report numbers: 1.3005168196-2017-02106, 2.3005168196-2017-02107, 3.3005168196-2017-02108, 4.3005168196-2017-02109, 5.3005168196-2017-02110, 6.3005168196-2017-02111, 7.3005168196-2017-02112 h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9262507
• MDR Text Key: 164493408
• Report Number: 3005168196-2019-02021
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR