MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE AB STENT; INTRACRANIAL NEUROVASCULAR STENT

Model Number SAB-4-20

Device Problems Material Deformation (2976); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  malfunction  

Event Description

Medtronic received information reporting that when the physician opened the solitaire ab (sab) stent packaging to prepare for use in the procedure per ifu, the stent was found to be broken so it was not used.As the issue was observed out-of-box and prior to use, there was no patient involved.Additional information received indicated the device packaging had been opened, and the inner packaging was incomplete.It was clarified that "broken" meant damaged.

Manufacturer Narrative

Product analysis: as found condition (condition of returned device): the solitaire ab revascularization device was returned for analysis within a shipping box; within a sealed biohazard-pouch and within an opened solitaire ab stent inner pouch.Visual inspection/damage location details: no bends or kinks were found with the solitaire pushwire.The marker coil was found to be intact.The pushwire was found to be broken ~1.28mm from distal end of marker coil.The detachment zone appeared to be damaged.The stent non-working (tear drop) length struts appeared to be in good condition.The middle working length and working length struts were found to be in good condition.The finger markers were found to be in good condition.Testing/analysis (including sem reports): the solitaire ab broken pushwire was sent out for sem (scanning electron microscopy) analysis for failure analysis of the broken end.Per the sem analysis report, the wire failed via tensile overload.No other anomalies were observed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿kink/damage¿ was confirmed as the pushwire was found to be broken.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the device analysis and reported information, the customers report of ¿product damaged/deformed out of pkg¿ was confirmed.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the formal investigation, user errors such opening package and removing device inadvertently kinking or otherwise damaging it during normal operation or handling damage during production at packaging could contribute to the event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOLITAIRE AB STENT
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12832219
• MDR Text Key: 281004970
• Report Number: 2029214-2021-01492
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: SAB-4-20
• Device Catalogue Number: SAB-4-20
• Device Lot Number: B046649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2020
• 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