MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-04-30 for INDY OTW VASCULAR RETRIEVER G51835 INDY-8.0-35-55-40 manufactured by Cook Inc.
[106864582]
The pma/510(k): k160593. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[106864583]
It was reported the male patient underwent an endovascular aneurysm repair (evar) procedure with an internal branched device (ibd). As reported, while snaring the wire through the pre-loaded catheter from the ibd the indy otw vascular retriever was difficult to remove and broke in the patient. There was no visible reason for the difficult removal. The catheter was removed but they had to retrieve the snare loop in the external iliac by a crossover procedure with an additional indy snare and the use of a single loop goose neck snare kit. The external iliac was stented with a self-expandable uncovered stent and the snare was retrieved successfully. The initial reporter stated "there was a lot of blood loss and it was a very long operation. " the patient has been released from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01042 |
| MDR Report Key | 7472243 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-30 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2017-12-15 |
| Date Added to Maude | 2018-04-30 |
| 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 |
| Brand Name | INDY OTW VASCULAR RETRIEVER |
| Generic Name | MMX DEVICE, PERCUTANEOUS RETRIEVAL |
| Product Code | MMX |
| Date Received | 2018-04-30 |
| Model Number | G51835 |
| Catalog Number | INDY-8.0-35-55-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2018-04-30 |