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

Model Number 427

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

The introducer, catheter, stent covering and hemostasis tools were all returned for evaluation.The covering was completely detached from the stent but intact.The stent was implanted in the patient with no issues or complications.The hemostasis tools were undamaged.The bib catheter was passed through the d'vill introducer.A slight catch was felt at the transition between the flange and the sheath.The hemostasis valve was removed from the introducer.One side of the flange had not been heated enough, leaving part of the sheath tubing exposed.A 0.110" gauge pin was passed through the transition.The pin caught on the exposed tubing.The complaint was confirmed since the covering had detached from the stent.It appears that the covering caught on the exposed end of the sheath tubing at the bond between the flange and the tubing.It is likely that the covering would have remained attached if not for this issue.All covered cp stents are inspected in final qc to ensure each covering has (4) acceptable glue spots.A sample from each lot is test for covering strength.The sample from this lot had a covering strength of 2.41lbs, which is well above the 1.5lb acceptance criteria.

Event Description

As per the incident report form received from the distributor - "patient with severe aortic coractation.Angioplasty with a covered cp stent was performed.During removal of the bib balloon the ptfe covering of the stent was found at the haemostatic membrane of the long sheath.After examination of the ptfe there was no piece missing.Patient remoained stable with no gradient across the arch." no intervention required."finally there was no adverse event and the coarctation was treated with a "non-covered" cp stent.".

• 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: 8651387
• MDR Text Key: 146495089
• Report Number: 1318694-2019-00013
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 05/29/2019

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: 07/31/2023
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z34
• Device Lot Number: CCP-0908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2018
• 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