MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature,other report with the FDA on 2019-05-06 for UNKNOWN manufactured by Cook Inc.
[144147482]
Product code = dqx. Occupation = unknown. Pma/510(k) number = pre-amendment. (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144147483]
As reported in the literature, following transfemoral aortic valve implantation (tavi) involving an (b)(6) year-old male patient, a ventral septal defect (vsd) was observed on a post-procedure echocardiogram. An unknown cook amplatz extra-stiff wire guide was used to deliver another manufacturer's valve. Post-procedural aortic regurgitation severity was reportedly mild. Echocardiography revealed membranous vsd. The patient had a high gradient between the left and right ventricles, supporting the diagnosis of restrictive-type vsd. Aortic valve calcification was said to be severe. At the one-year follow-up, the patient was reportedly hemodynamically stable. The vsd was not considered to be clinically significant, and no further intervention was required. The authors make several hypotheses regarding the formation of the vsd in this case. The first is direct trauma caused by the bioprosthetic valve by overestimation of the size leading to high pressure being exerted on the left ventricular outflow tract and septum, leading to tearing of the septum. The second hypothesis is that the concentrated amount of calcium on the aortic valve and left ventricular outflow tract perimeter could lead to vsd formation. This is thought to be the result of pushing/pressing of the valve into the septum. The final hypothesis for the formation of the vsd is the result of indirect trauma to the distal or apical interventricular septum caused by the stiff wire. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01104 |
| MDR Report Key | 8582548 |
| Report Source | FOREIGN,LITERATURE,OTHER |
| Date Received | 2019-05-06 |
| Date of Report | 2019-07-10 |
| Date Mfgr Received | 2019-07-08 |
| Date Added to Maude | 2019-05-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | DQX WIRE, GUIDE, CATHETER |
| Product Code | DXQ |
| Date Received | 2019-05-06 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-05-06 |