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

Model Number 427

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint stent was returned to numed.It was reported by the foreign distributor that the stent was separated from the guidewire upon opening the package.Numed does not send a guidewire with the stents, so it was unknown as to what the complaint actually was.Upon receipt of the device, an evaluation was performed.Three of the adhesive spots are detached.One end of the stent has been slightly flattened.The od of the stent at this end is 0.174".8 zig stents have an od of 0.181" when they are shipped.The other end was still the 0.181".Four adhesive spots are visible on the covering.The root cause of the complaint cannot be determined due to the lack of information provided.All covered cp stents are inspected for proper covering attachment in final inspection.A sample from each lot is tested for covering attachment strength.The sample from this lot of stents had a covering attachment strength of 2.87lbs, which is well above the minimum specification.The device history record was reviewed and no issues were found.All devices met criteria for release.Additional information was received on (b)(6) 2019 - the report stated - "stent crimping (cvd cp 45 mm stent) in the balloon (22 x 50 mm bib) was performed as usual by manually tightening the stent throughout the stent alternatively in various orientations without rolling it between the fingers.Before advancing into the delivery sheath, i realized that the stent cover was detached from the metal frame, moving freely over it so it was not placed on the patient and was replaced by another stent of the same size and mounted in the same balloon." "the procedure was successful and without complications." "stent was replaced with another one." visual inspection was performed on the stent when it was returned.Even though one end of the stent was flattened, it was determined that this stent had not been crimped at all.It is unknown as to what happened with this stent due to the lack of information, as well as the inaccurate information, provided by the distributor.

Event Description

As per the foreign distributor - "we're still waiting for the customer's report but we know that when opening the package, the stent was already separated from the guidewire.There was no contact with the patient." numed's covered cp stent is not sent with a guidewire, so it was unknown as to what the problem was at the time the complaint was received via email.The stent was returned to numed on (b)(6) 2019 the lot number that was provided to numed was not correct.It was reported that the issue was with ccp-1028, but when the device was received, the box said ccp-1028 but the product inside was in a bottle labeled ccp-0947.The distributor was contacted about this again.They confirmed that the complaint device was ccp-0947, but the device was placed in the box of the product that was used on the patient with no issue ccp-1028.Ccp-0947 was reviewed and it was determined that there was a stent covering issue with the returned device.Updated report received from the distributor on (b)(6) 2019 - "stent crimping (cvd cp 45 mm stent) in the balloon (22 x 50 mm bib) was performed as usual by manually tightening the stent throughout the stent alternatively in various orientations without rolling it between the fingers.Before advancing into the delivery sheath, i realized that the stent cover was detached from the metal frame, moving freely over it so it was not placed on the patient and was replaced by another stent of the same size and mounted in the same balloon." "the procedure was successful and without complications." "stent was replaced with another one.".

• 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: 9475106
• MDR Text Key: 209842407
• Report Number: 1318694-2019-00026
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2019

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: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• 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: 26 YR