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

Model Number 427

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

The covered cp stent was not returned to numed, so the malfunction could not be confirmed.One stent from the lot was pulled and tested for covering strength before the lot was released for distribution.The stent met all criteria for covering strength as per the specification.

Event Description

As per the report from the physician and distributor - "the ptfe was detached from the cp when the physician took it.It happened before the procedure.".

• 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: 7483641
• MDR Text Key: 107710212
• Report Number: 1318694-2018-00005
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2018

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: No Information
• Device Expiration Date: 08/31/2020
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 55