MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-07-22 for INDY OTW VASCULAR RETRIEVER INDY-8.0-35-55-40 manufactured by Cook, Inc..
[4748703]
A (b)(6) male with preexisting aaa due to significant type 1b endoleak (1820334-2014-00322) from existing aaa graft which was implanted in 2012 was having evar. The endoleak had occurred due to progressive aneurysmal disease with dilation of the right cia. The physician elected to come from the arm to embolize the r) iia had to snare the wire using the indy snare. As the physician snared the wire and withdrew the snare. There appeared to be resistance and instead of stopping, the physician pulled quite hard and the looped snare became detached from the indy device (1820334-2014-00314). The physician tried unsuccessfully to snare the insitu nitinol loops of the indy snare before electing to leave this insitu; pushing it against the wall of the artery with a zenith iliac leg graft; which was utilized to occlude the endoleak. This was completed successfully and the final run was good demonstrating that the aneurysmal sac was no longer filling. Cook medical sales rep follow up with the physician in the morning - patient was recovering well and the physician was happy with the outcome. The physician advised the cook rep that she did not feel it was necessary to report this occurrence and was happy for cook medical to make a note of the occurrence for their records.
Patient Sequence No: 1, Text Type: D, B5
[12375760]
(b)(4). Event evaluation: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2014-00314 |
| MDR Report Key | 3981122 |
| Report Source | 01,08 |
| Date Received | 2014-07-22 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-06-24 |
| Date Facility Aware | 2014-06-24 |
| Report Date | 2014-06-24 |
| Date Mfgr Received | 2014-06-30 |
| Device Manufacturer Date | 2013-09-23 |
| Date Added to Maude | 2014-08-06 |
| 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 | RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDY OTW VASCULAR RETRIEVER |
| Generic Name | GAE SNARE, SURGICAL |
| Product Code | GAE |
| Date Received | 2014-07-22 |
| Model Number | NA |
| Catalog Number | INDY-8.0-35-55-40 |
| Lot Number | 4521408 |
| ID Number | NA |
| Device Expiration Date | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-22 |