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

Model Number 427

Device Problems Detachment Of Device Component (1104); Device Slipped (1584); Use of Device Problem (1670); Failure to Advance (2524)

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

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

Stent returned to numed completely mangled the covering was not returned.Further analysis is not possible due to the condition of the stent and the absence of the covering.The detachment of the covering is confirmed.This was the physician's first time using this device unaided, so it is likely that inexperience played a role in the failure.The report states that the physician used " 16 and 18" f hemostasis tools to insert the stent in to a 12f introducer.Numed only provides 12, 14 and 16f hemostasis tools with unmounted stents.If a 16f hemostasis tool was used with a 12f introducer, the distal end of the hemostasis tool would have collapsed, making it difficult to advance the stent.The use of umbilical tape to crimp the stent may have also contributed to the failure.Numed recommends crimping the stent by hand.Crimping instructions are included in the instructions for use and there is an instructional video on numed's website.A sample from this lot was tested for covering strength.The covering failed at 2.54 lbf, which is above the 1.5 lbf minimum.This complaint was for (2) covered cp stents.The other stent will be reported through mdr # 1318694-2017-00012.

Event Description

As reported by braun: " crimped on to bib balloon, inserted to sheath with the hemostasis tool the cover came back and rolled off.This happened two times.Went in and out of the hemostasis valve multiple times physician re-crimped it.Account said it could be operator error, physician's first time using stent unaided.As stent was advancing through, it kept coming off of the balloon.There was no difficulty mounting the balloon.The size of the catheter the stent was mounted on: 16 mm x 4.5 cm both, 2.2 stent 3.4 stent.Both saline and contrast media were used during prep.The hemostasis tools were used that are provided by numed - thse sizes: 16 & 18.The stent started slipping during insertion through the sheath.The inner balloon was inflated before the outer balloon once the 2 successful stents were deployed.They attempted to pull the stent back through the hemostasis valve to get it out.Crimping process used: ring mandril through end of balloon with stent on it, put it in between markers (2 outer image bands) compressed with thumb and index rolled it.Used umbilical tape to wrap around stent and further crimp down.The indication the physician was using the balloon for - co-arc.An inflation device with pressure gauge was used.The size and type of introducer sheath used - 12 f long mullin.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.The patient condition post procedure: patient ok.Successfully placed 3.9 & 3.4 stents.Used 3.9 w/ 12f 16x4.5 3.4 14f sheath & 16x3.5." on (b)(6) 2017 - from a conversation the bis sale specialist had with the account: "sequence of events - crimped on to bib balloon.Inserted into sheath with the hemostasis tool.Was unable to advance into sheath, physician attempted to advance multiple times and the cover would come back and roll off.Physician stated this happened when attempted two times.After removing again, physician attempted to re-crimp it, and was unsuccessful as the cover rolled off again.".

• 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: melissa thomas ; 2880 main street; hopkinton, NY 12965
• MDR Report Key: 6581064
• MDR Text Key: 75835919
• Report Number: 1318694-2017-00013
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046964898907
• UDI-Public: 04046964898907
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2021
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z34
• Device Lot Number: CCP-0679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 70