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

Model Number 428

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913); Activation Failure (3270)

Patient Problem Death (1802)

Event Type  malfunction  

Manufacturer Narrative

The stent was implanted in the patient, so it was not returned to numed.The catheter was also not returned to numed for evaluation.The root cause of the complaint cannot be positively determined, however, patient anatomy may have been a factor.As per the report from the physician, the patient's conduit was very calcified in the distal third portion of the stent, so the stent would not have sat flat in that area, and an endoleak would have still been there.This product has the following contraindication in the instructions for use: " unfavorable patient anatomy that does not dilate with high pressure balloon angioplasty." all of numed's mounted stents are inspected at final qc to ensure that the stent is firmly crimped on the balloon.

Event Description

As per the 11/16/2016 report from the distributor/hospital - "used 18mm covered mounted stent for a conduit rupture, the stent partially slipped off the balloon.Account was able to manipulate it back on to the balloon, but as they inflated the outer balloon it started to slip off again.The distal 1/3 of the stent did not expand, leaving the rupture uncovered.They tried to get a balloon into the distal portion of the stent to expand it but were not successful, as the patient was coding and had to be sent to the or.An inflation device with pressure gauge was used.A 14mm sheath was used." additional information received from the distributor/hospital on 12/1/2016 - "from conversation bis sales rep had with account: hemostasis tools were used.Stent started slipping when physician got towards end of sheath, he noticed it slipped off proximally, then was able to get balloon centered back in stent.Stent later slipped off distally upon inflation of second balloon which caused distal third not to expand.Inner balloon was inflated before outer balloon.At no time was stent pulled back through hemostasis valve.They could not get the 1st stent superior and were trying to place a 2nd stent.Second (2nd) stent did not catch on 1st, it was still in sheath.He felt no resistance, and checked to see if sheath had kinked, but it had not.Patient died in or.Physician said conduit was very calcified in the distal third portion, so if it deployed properly, stnet would not have sat flat, and would still have endoleak.They removed the bib, tried another 18mm balloon, could not get it to expand stent.Cook checkflow sheath used, account understands some sheaths are not upsized, experienced with cook sheath, and never felt resistance.".

Manufacturer Narrative

The stent was implanted in the patient, so it was not returned to numed.The catheter was also not returned to numed for evaluation.The root cause of the complaint cannot be positively determined, however, patient anatomy may have been a factor.As per the report from the physician, the patient's conduit was very calcified in the distal third portion of the stent, so the stent would not have sat flat in that area, and an endoleak would have still been there.This product has the following contraindication in the instructions for use: " unfavorable patient anatomy that does not dilate with high pressure balloon angioplasty." all of numed's mounted stents are inspected at final qc to ensure that the stent is firmly crimped on the balloon.Update: additional information was received by the manufacturer.This device was being used for a rupture of an aortic homograft.This device's approval is for coarctation of the aorta.

Event Description

As per the (b)(6) 2016 report from the distributor/hospital - "used 18mm covered mounted stent for a conduit rupture, the stent partially slipped off the balloon.Account was able to manipulate it back on to the balloon, but as they inflated the outer balloon it started to slip off again.The distal 1/3 of the stent did not expand, leaving the rupture uncovered.They tried to get a balloon into the distal portion of the stent to expand it but were not successful, as the patient was coding and had to be sent to the or.An inflation device with pressure gauge was used.A 14mm sheath was used." additional information received from the distributor/hospital on 12/1/2016 - "from conversation bis sales rep had with account: hemostasis tools were used.Stent started slipping when physician got towards end of sheath, he noticed it slipped off proximally, then was able to get balloon centered back in stent.Stent later slipped off distally upon inflation of second balloon which caused distal third not to expand.Inner balloon was inflated before outer balloon.At no time was stent pulled back through hemostasis valve.They could not get the 1st stent superior and were trying to place a 2nd stent.Second stent did not catch on 1st, it was still in sheath.He felt no resistance, and checked to see if sheath had kinked, but it had not.Patient died in or.Physician said conduit was very calcified in the distal third portion, so if it deployed properly, stent would not have sat flat, and would still have endoleak.They removed the bib, tried another 18mm balloon, could not get it to expand stent.Cook checkflow sheath used, account understands some sheaths are not upsized, experienced with cook sheath, and never felt resistance.".

• Brand Name: COVERED AND MOUNTED 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: 6147705
• MDR Text Key: 62331601
• Report Number: 1318694-2016-00010
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046964899485
• UDI-Public: 04046964899485
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

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: Physician
• Device Expiration Date: 07/31/2021
• Device Model Number: 428
• Device Catalogue Number: CMCP019
• Device Lot Number: CMCP-1377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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: 23 YR