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

Model Number 427

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

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

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

None of the devices were returned for review.A review of the device history records was performed and no issues were noted.There are no other complaints associated with this stent lot number.The physician provided additional information via an email.She stated - "the problem was that immediately behind the homograft the pulmonary braches went perpendicularly and there was hardly any space, while the distal end of the homograft had severe narrowing.Maybe that is why the stent moved." based on the additional information as well as the information previously provided, it seems that the migration of the stent was due to patient anatomy.

Event Description

Numed received a post market clinical follow-up report from the eu in regards to a stent migration.The full write-up is as follows: stenotic pulmonary homograft, 28mm, complex anatomy, homograft stenotic at distal end.Directly after stenotic part in 90 degree angle are the ostia of pulmonary arteries.Plan: prestenting and melody valve.After balloon sizing, prestent 39mm 10 zig on 28mm bib balloon.Inner balloon inflated first.Good deployment stent, however, stent dislocated to proximal rvot direction and is unstable.Second stent, covered 49mm 10 zig on 30mm bib balloon.Placed in first stent in homograft/rvot, but not stable: second stent is fixed nicely on distal homograft but first stent moved further in rvot.Third stent 49mm 10 zig uncovered on bib balloon 30mm placed between both stents, trying to stabilize first two stents.In the first place it seems to be a stable ensemble of 3 stents, but some minutes later the two proximal stents dislocate to rv (still on wire).Patient went for surgery (wire in place), where stents were removed and homograft replaced by other homograft.Good result.Patient recovered completely.Conclusion: at prestenting stenotic homograft (difficult anatomy) dislocation of stent 39mm 10zig rvot.Efforts to stabilize stent in homograft with two more stents was not successful.Stents could be deployed nicely.All stent were fully expanded.No issue with stent 2 or 3 which were used for rescue efforts.

• Brand Name: COVERED CP STENT
• Type of Device: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton, ny
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton, ny
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, ny ; 3284491
• MDR Report Key: 10489103
• MDR Text Key: 205552401
• Report Number: 1318694-2020-00008
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 427
• Device Catalogue Number: CVRDCP10Z39
• Device Lot Number: CCP-1092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 30 YR