MAUDE Adverse Event Report: COVIDIEN SPIDER FX; DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC

Catalog Number UNK-PLY-SPIDER

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

Patient Problem Thrombus (2101)

Event Date 04/01/2006

Event Type  Injury  

Manufacturer Narrative

Clinical research - coronary interventions eurointervention 2014;10:689-693 estimate of date study began.It went on until dec 2011.Cine image review: ten images from the procedure were published in the article.In the images, it can be seen that the spiderfx filter was being advanced in a vessel without the spiderfx catheter.Thrombus emboli and its removal can also be seen in the images.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Background: during a study, the physician attempted to use a spider embolic protection device to capture and remove a large non-occlusive coronary thrombus from a number of patients, if required.The general protocol used was - a 6f or 7f guide catheter was used.Target vessel was greater than or equal to 3 mm.Aspiration with a medtronic aspiration catheter was attempted in all cases.If this was unsuccessful, a second coronary wire was advanced across the lesion.A spider device was then advanced over one of the wires into the distal vessel and its basket opened.The size of device was chosen to be one size larger than the distal reference vessel diameter.Following successful capture of the thrombus, the retrieval catheter was used to close the neck of the basket and the device was removed.If residual thrombus was present, the spider device was reintroduced and the withdrawal procedure repeated.The patient identified as case 8 in the study was diagnosed with non-st segment elevation myocardial infarction(nstemi).It is reported this patient had a substantial thrombus burden at the right coronary artery(rca) and required passage of the filter device three times for complete removal of the thrombus.Following the final passage of the spider device, a small thrombus embolised to a sub-branch of the posterior left ventricular branch.This small occlusive embolic thrombus was completely removed using a medtronic aspiration device.The lesion was then stented over with no evidence of further embolisation.No further patient complications reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPIDER FX
• Type of Device: DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6102163
• MDR Text Key: 59867212
• Report Number: 2183870-2016-00664
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-PLY-SPIDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR