MAUDE Adverse Event Report: MEDTRONIC (IRVINE) SOLITAIRE REVASCULARIZATION DEVICE; CATHETER, THROMBUS RETRIEVER

Model Number SFR2-6-30

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

Patient Problems Intimal Dissection (1333); Death (1802); Hemorrhage, Cerebral (1889)

Event Date 04/07/2015

Event Type  Death  

Event Description

Medtronic (covidien) received information through clinical data review that a patient was treated with a solitaire fr2 for a left m2 occlusion of the middle cerebral artery (mca).Tici 3 was achieved with 1 pass of solitaire fr2.One day post procedure, it was reported that both an intracerebral hemorrhage and femoral artery thrombosis (due to injury of the intima by the closure device) occurred on the right side.No intervention was required for the intracerebral hemorrhage; however, the right femoral artery thrombosis required thromboendarterectomy and pericardial patch angioplasty repair.After the hemorrhagic conversion, the patient was turned to dnr (do not resuscitate).These events were reported to have been procedure related.The patient expired three days after the initial treatment procedure.The death was reported to have been caused by hemorrhagic conversion.

Manufacturer Narrative

The device was not retuned for analysis as it was discarded.The lot history record review of the reported lot numbers showed no discrepancies that might have contributed to the reported experience.Based on the reported information, there did not appear to have been any defect of the device during its use.The event occurred in the patient post procedure and its cause was unknown.(b)(4).

• Brand Name: SOLITAIRE REVASCULARIZATION DEVICE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MEDTRONIC (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 4754017
• MDR Text Key: 5822197
• Report Number: 2029214-2015-00500
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2017
• Device Model Number: SFR2-6-30
• Device Lot Number: A060454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• 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): Death
• Patient Age: 73 YR