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

Model Number	427
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint stent was not returned so the root cause of the complaint cannot be positively determined, however, there are a few factors that could have contributed to the detachment.The stent was crimped down on an 18mm bib, which is well below the recommended 26mm minimum.Crimping a 10 zig stent on a smaller bib would cause the zigs at the end of the stent to overlap.This would increase the probability of a detachment by adding stress to the covering's adhesive spots.The ring mandril was not used during the crimping process.The mandril reduces the risk of bending the stent, which can also stress the covering's adhesive spots.The stent had been soaking in ns with heparin solution 15 minutes prior to crimping.The ifu and stent mounting procedure recommend crimping dry stents.All covered and mounted cp stents are inspected for proper covering attachment in final inspection.A sample from each lot is tested for covering strength.The sample from this lot failed at 3.49lbs, well above the 1.5lb minimum.The production traveler (dhr) was reviewed and no issues were found.All devices in this lot met the criteria for release and distribution.There are no other associated complaints with this lot of devices.
Event or Problem Description
As per the report from the user facility / distributor - after crimping the covered stent on a 18mm od bib balloon - prior to advancing in 22mm gore dryseal sheath, the covering was noted to be completely off the stent.It had been soaking in ns with heparin solution 15 minutes prior to crimping.Indication the physician was using the stent: sinus venosus asd closing.There was no difficulty mounting the stent.Process for crimping: squeezed stent.The ring mandril was not used during the crimping process.The stent did not slip.Covering came off prior to introduction into sheath.The blue introducer tool was not used.The catheter shaft was not kinked.Another covered cp stent was used to complete the procedure without incident.The patient was fine post procedure.

• Brand Name: COVERED CP STENT
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 12591612
• Report Number: 1318694-2021-00008
• Device Sequence Number: 3413490
• Product Code: PNF
• UDI-Device Identifier: 04046955091218
• UDI-Public: 04046955091218
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 427
• Device Catalogue Number: CVRDCP10Z55
• Device Lot Number: CCP-1033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 43