MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Catalog Number SEPX-8-6-40-135

Device Problem Device-Device Incompatibility (2919)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use a protege rx stent to treat a lesion in the common carotid artery.The lesion was not pre-dilated.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped without issue.A spiderfx was used as embolic protection.The device did not pass through a previously deployed stent, no resistance was encountered nor excessive force used when advancing the device to the lesion.The spider was deployed at the site and the stent was deployed at the intended target lesion without issue.Upon withdrawal, the devices became stuck and locked up with each other.A 3x8mm balloon was used at the iliac artery to anchor the spider wire and a cut down was performed to change to a ¿mono rail system¿.The devices were retrieved.The patient was transferred to icu and is reported to be doing well.

Manufacturer Narrative

Additional information: upon withdrawal the stent's inner sheath stuck to the spider.The inner sheath was removed, the inner wire was cut down and removed.The stent delivery system was withdrawn, and the spider was retrieved using its blue retrieval portion.No surgical intervention was required to remove the devices.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: the spiderfx device was examined: the device was returned with the capture wire observed out of the dual ended delivery catheter.A kink was observed on the spiderfx capture wire.A fracture of the proximal end of the capture wire was noted.Multiple kinks and tensional stretching were noted on the blue recovery end of the dual ended catheter.No abnormality was noted on the green delivery end of the dual catheter.No abnormality observed on the spiderfx filter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: one image was received from the customer.Per the image, a detachment of the inner distal assembly proximal to the retainer.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8487141
• MDR Text Key: 141050113
• Report Number: 2183870-2019-00163
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2019
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A526994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• 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): Hospitalization
• Patient Age: 74 YR
• Patient Weight: 52