MAUDE Adverse Event Report: NUMED, INC. COVERED CP STENT; AORTIC STENT

Model Number 427

Device Problem Component Falling (1105)

Patient Problem No Information (3190)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

The detachment of the covering has been confirmed.The covering was undamaged, but returned bloody.All four glue spots were confirmed.There was minimal information available for this complaint.The distributor stated that they are unable to get more information.The stent has been flattened and the zigs are overlapped.It is unknown if the hemostasis valve tools were used for the introduction of the covered cp stent into the hemostasis valve of the introducer.The mounting procedure provided with the instructions for use specifically states that these tools are to be used for inserting the covered cp stent into the hemostasis valve of the introducer.It is likely that these tools were not used, but numed is unable to confirm this.

Event Description

As per the report from the distributor: "cover fell off when passing the hemstatic valve on the cook sheath.".

• Brand Name: COVERED CP STENT
• Type of Device: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 6177055
• MDR Text Key: 62849846
• Report Number: 1318694-2016-00013
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046964898792
• UDI-Public: 04046964898792
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2021
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z28
• Device Lot Number: CCP-0686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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 Age: 14 YR
• Patient Weight: 57