MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR4; CATHETER, THROMBUS RETRIEVER

Model Number	SFR4-6-40-10
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is being reported at this time based on analysis results.Product analysis findings: the solitaire fr revascularization device was returned for analysis within a shipping box and within a resealable biohazard-pouch.The marksman catheter used during the event was not returned for analysis.The model and lot numbers were not provided for the phenom catheter; therefore, compatibility could not be assessed.The solitaire fr revascularization device was returned without its introducer sheath.The pushwire was found to be broken but retained by outer liner at ~159.0cm from proximal end.No bends or kinks were found with the marker coil.The outer shrink tubing was removed.No corrosion was found on the broken end of the pushwire.The solitaire fr stent was sent out for sem (scanning electron microscopy) analysis for failure analysis of the broken pushwire.Per the sem analysis report, fatigue cracking initiated from the wire surface is visible.The rest of the wire failed via overload.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿resistance during retrieval¿ could not be confirmed as the pushwire was found to be broken.Therefore, the device could not be used for resistance testing.Resistance can be caused by compatibility, lack of continuous flush or extremely tortuous anatomy.Based on the device analysis and reported information, the customer¿s report of ¿kink/damaged¿ was confirmed as the pushwire was found broken.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the solitaire fr 4 experienced resistance in a phenom 21 microcatheter, and it was later found to be damaged.The patient was undergoing treatment for a mechanical thrombectomy.Patient medical history included stroke.It was reported that one pass was performed using the phenom 21 microcatheter and resistance was perceived.The physician replaced with catheter with a microvention.027 catheter, and the device traveled more smoothly.After two more passes the device was noted to have been broken and the plastic sheath was stuck to the pusher wire.The solitaire was replaced, the procedure was completed successfully, and a tici score of 2b/c was achieved. the patient did not experience any injury or complications.Additional information received reported that there was no kink or damage on the catheter.The tip of the solitaire sheath was secured into the hub of the microcatheter.It was stated the device was not flushed.Additional information received reported that resistance was felt in the middle part of the catheter.

• Brand Name: SOLITAIRE FR4
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12257056
• Report Number: 2029214-2021-00960
• Device Sequence Number: 4689730
• Product Code: NRY
• UDI-Device Identifier: 00847536034730
• UDI-Public: 00847536034730
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K203358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: SFR4-6-40-10
• Device Catalogue Number: SFR4-6-40-10
• Device Lot Number: B081146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1