MAUDE Adverse Event Report: CORDIS CORPORATION CAROTID NITINOL STENT; UNKNOWN

Catalog Number J629EXX

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage, Cerebral (1889); Weakness (2145); Dysphasia (2195)

Event Date 05/17/2008

Event Type  No Answer Provided  

Manufacturer Narrative

The product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by medical affairs, a patient called claiming that on (b)(6) 2008 he had an unknown stent placed in the "left main carotid artery".An unknown coil was placed in an unknown area in the brain due to a cat scan in 2008 showing the re-development of the brain aneurysm".In (b)(6) 2008, the patient reports having "right arm issues and became aphasic" unsure if due to brain aneurysm.Treatment not obtained at time of call.On (b)(6) 2008, the patient reports that "my head started to bleed again" and as treatment had another unknown stent and coil placed.Unknown if patient was hospitalized at time of event.In (b)(6) 2008, the patient reports having two titanium clips placed on right side of brain for unknown reason, hospitalization unknown.No further information could be obtained at time of call, the patient claimed to be "reluctant to give any more information".

Manufacturer Narrative

Complaint conclusion: as reported by medical affairs, a patient called claiming that on (b)(6) 2008 he had an unknown stent placed in the ¿left main carotid artery¿.An unknown coil was placed in an unknown area in the brain due to a cat scan in 2008 showing the re-development of the brain aneurysm¿.In (b)(6) 2008, the patient reports having "right arm issues and became aphasic¿ unsure if due to brain aneurysm.Treatment not obtained at time of call.On (b)(6) 2008, the patient reports that ¿my head started to bleed again¿ and as treatment had another unknown stent and coil placed.Unknown if patient was hospitalized at time of event.In (b)(6) 2008, the patient reports having two titanium clips placed on right side of brain for unknown reason, hospitalization unknown.No further information could be obtained at time of call, the patient claimed to be ¿reluctant to give any more information".The product remains implanted in the patient and thus is not available for evaluation.Additionally, as the sterile lot number was not available, device history record review could not be performed.Aphasia and right arm weakness are symptoms of tia, is a well-known potential adverse event associated with the carotid stent implantation procedure.The event of the cerebral bleeding might be associated to the patient¿s medical history of brain aneurysm.There is no evidence that manufacturing issues contributed to the event.

• Brand Name: CAROTID NITINOL STENT
• Type of Device: UNKNOWN
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5155729
• MDR Text Key: 28484669
• Report Number: 9616099-2015-00493
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: J629EXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 82