MAUDE Adverse Event Report: COOK INC INDY OTW VASCULAR RETRIEVER; MMX DEVICE, PERCUTANEOUS RETRIEVAL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Evaluation / investigation.The actual complaint device was not returned.A documentation based investigation was performed including a review of complaint history, the instructions for use, quality control data, and specifications.Each device is shipped with instructions for use (ifu), listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.The ifu precautions state, ¿manipulation of the product requires fluoroscopic control.Visually inspect the product before use to ensure it is undamaged.¿ the device history record review and a review of complaint history records for this device/lot was not able to be performed as the lot number of the complaint device was not provided.This complaint focuses on an indy otw vascular retriever that was unable to pull a figulla flex ii double disk 25 mm pfo occluder system through the iliac bifurcation.The figulla flex ii double disk 25 mm pfo occluder system was too large to fit through the iliac bifurcation.Based on the imaging and information provided in the journal article there is no alleged product malfunction.A complaint of similar nature has not been previously reported to cook.There is no evidence to suggest the product was not manufactured to current specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.Based on current information, no alleged malfunction of the device occurred.There is no evidence to suggest any causal relationship between the indy otw vascular retriever and the need to perform laparotomy/lateral arteriotomy of the infrarenal aorta procedure to remove the figulla flex ii double disk 25 mm pfo occluder system.The indy otw vascular retriever functioned as intended until the aortic bifurcation which was too small for the figulla flex ii double disk 25 mm pfo occluder system.Based on current information, it appears the use of the indy otw vascular retriever in this case was not appropriate.The laparotomy and lateral arteriotomy of the infrarenal aorta was probably the only real option to remove the figulla flex ii double disk 25 mm pfo occluder system.The journal author concludes, "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." the investigation conclusion for this incident is no problem detected.As there is no alleged malfunction of the device; risk documentation was not reviewed.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new event information received.

• Brand Name: INDY OTW VASCULAR RETRIEVER
• Type of Device: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8354567
• MDR Text Key: 136729773
• Report Number: 1820334-2019-00329
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR