MAUDE Adverse Event Report: COVIDIEN (IRVINE) CAPTURE LP; CATHETER, THROMBUS RETRIEVER

Model Number 300016

Device Problem Difficult to Remove (1528)

Patient Problem Intimal Dissection (1333)

Event Date 05/11/2015

Event Type  Injury  

Event Description

Medtronic received information that during a mechanical thrombectomy treatment of a patient with ischemic stroke, the physician reported that the capture lp device could not retrieve the clot and the patient experience a mid-mild m2 artery dissection.The patient was brought in with aphasia and left hemiplegia and was diagnosed with ischemic stroke due to clot in the m2 segment of the middle cerebral artery (mca).The mca was reported to be extremely tortuous.The first revascularization device was unable to hold onto the clot upon removal.Therefore, the physician decided to retrieve the clot with a capture lp 3x23.However, the more "rigid" capture lp was unable to be pulled out of this anatomy (mdr# 2029214-2015-00649).The physician had to push the marksman microcatheter over the capture lp in order to get it out.This process dissected the m2 artery per procedural image (mdr# 2029214-2015-00634).No treatment was needed for the mild m2 artery dissection.The patient's condition was reported to be improving three days post procedure.

Manufacturer Narrative

The lot history record of the reported lot number has been reviewed and no quality issues were noted.The device will not be returned for analysis as it was discarded; therefore, the event cause could not be determined.Same event as reported in mdr# 2029214-2015-00634.

• Brand Name: CAPTURE LP
• 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 ; 9496801224
• MDR Report Key: 4828696
• MDR Text Key: 5912672
• Report Number: 2029214-2015-00649
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2017
• Device Model Number: 300016
• Device Lot Number: 150313-002
• Other Device ID Number: 00847536020139170313150313-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2015
• 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): Other
• Patient Age: 60 YR