MAUDE Adverse Event Report: COVIDIEN (IRVINE) SOLITAIRE RD; CATHETER, THROMBUS RETRIEVER

Model Number SRD-4-20

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/17/2012

Event Type  Injury  

Manufacturer Narrative

This event was initially submitted under mdr# 2029214-2012-00366.Updated section: a- with the patient's age and gender.D- udi only the detach wire was returned for evaluation.The solitaire will not be returned for evaluation as it was remained in the patient.Visual inspection showed no irregularities outside of the detachment zone area.The stent appeared to be broken at the proximal of the non-working length struts (teardrop struts).The fracture surfaces were then sent out for sem analysis.No other anomalies were observed.Based on the above findings and the sem images, the report was confirmed.Fracture surfaces exhibited features consistent with overload failure.

Event Description

Citation: unwanted detachment of the solitaire device during mechanical thrombectomy in acute ischemic stroke.¿j neurointerv surg.2016 jan 27.Pii: neurintsurg-2015-012156.Doi: 10.1136/neurintsurg-2015-012156.[epub ahead of print] solitaire fr was used to treat middle cerebral artery occlusion.The admission nihss was 15.2 passes (one pass in the superior branch and one in the inferior branch).The detachment occurred distal to the proximal mark.This device was not removed and was left in the patient.Mrs at 90 days was 3.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOLITAIRE RD
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 6401457
• MDR Text Key: 69839139
• Report Number: 2029214-2017-00180
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K113455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2014
• Device Model Number: SRD-4-20
• Device Lot Number: 9562711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2012
• 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): Disability
• Patient Age: 69 YR