MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-20 for INDY OTW VASCULAR RETRIEVER UNKNOWN manufactured by Cook Inc.
[136729773]
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
[136729774]
An adverse event report was identified in the journal article: a. Frech et al. , surgical pfo occluder system retrieval; case report, vasa (2017), volume 46(4), pp 310? 312. This information was retrieved from: https://doi. Org/10. 1024/0301-1526/a000620. The case report states,? Percutaneous closure of a large (8 x 3 mm in 3-dimensional transoesophageal echocardiography; (see figure 1) pfo with a pronounced atrial septum aneurysm was indicated in a (b)(6) male with a history of paradoxical embolism leading to stroke caused by a lower leg deep venous thrombosis. A figulla flex ii double disk 25 mm pfo occluder system (occlutech? Gmbh, jena, germany) was successfully placed (normal wiggle test, regular right atrial angiogram before device release) without any immediate periprocedural complications (see figure 2). Transoesophageal echocardiogram on the first post-procedural day surprisingly showed a dislocated occluder system which was consecutively detected by computed tomography, located in the abdominal aorta close to the origin of the mesenteric vessels (see figure 3). The passage of the device through the left heart to the abdominal aorta occurred without symptoms reported by the patient. Interventional retrieval through the right femoral artery was intended, using an indy otw vascular retriever (cook medical europe ltd. Limerick, ireland). It was possible to snare the occluder system and to pull it down from the proximal abdominal aorta to the level of the aortic bifurcation (see figure 4). At this position the occluder system was trapped at the aortic wall and finally could not be retrieved through a sheath. Therefore, an open surgical retrieval was indicated, which was successfully achieved by laparotomy and lateral arteriotomy of the infrarenal aorta (see figure 5). The postoperative course was uneventful and the patient was dismissed from the hospital on the seventh postoperative day. Readmission for surgical closure of the pfo and resection of the atrial septum aneurysm was planned at discharge?. (a. Frech et al. , 2017). ? We report a very rare complication of clinically asymptomatic device embolization to the abdominal aorta. In previously published cases of pfo occluder device embolization, device retrieval could be achieved through percutaneous intervention [4, 5, 6]. In our case, endovascular retrieval of the dislocated occluder system was unsuccessful because of trapping of the system near the aortic bifurcation. Therefore open surgery was indicated. Using a standardised transperitoneal approach, the occluder device was removed via arteriotomy". (a. Frech et al. , 2017).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00329 |
| MDR Report Key | 8354567 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-20 |
| Date of Report | 2019-03-26 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-02-20 |
| 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 | 2019-02-20 |
| 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. Required No Informationntervention | 2019-02-20 |