MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-06 for COVERED AND MOUNTED CP STENT 428 CMCP019 manufactured by Numed, Inc..
[62331601]
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.
Patient Sequence No: 1, Text Type: N, H10
[62331603]
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. "
Patient Sequence No: 1, Text Type: D, B5
[63924280]
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.
Patient Sequence No: 1, Text Type: N, H10
[63924281]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2016-00010 |
| MDR Report Key | 6147705 |
| Date Received | 2016-12-06 |
| Date of Report | 2016-12-02 |
| Date Mfgr Received | 2016-11-16 |
| Device Manufacturer Date | 2016-07-12 |
| Date Added to Maude | 2016-12-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICHELLE LAFLESH |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal | 12965 |
| Manufacturer Phone | 3153284491 |
| Manufacturer G1 | NUMED, INC. |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12965 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COVERED AND MOUNTED CP STENT |
| Generic Name | AORTIC STENT |
| Product Code | PNF |
| Date Received | 2016-12-06 |
| Model Number | 428 |
| Catalog Number | CMCP019 |
| Lot Number | CMCP-1377 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED, INC. |
| Manufacturer Address | 2880 MAIN STREET HOPKINTON NY 12965 US 12965 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-06 |