MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR SANTA ROSA ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number SA-85

Device Problems Device Expiration Issue (1216); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Conclusion: failure to follow instructions (using expired product).

Event Description

An endurant aui stent graft system was implanted in a patient for the endovascular treatment of a 57.9x62.7mm in diameter abdominal aortic aneurysm.The vessels were moderately tortuous with mild calcification.The patient had a reverse conical neck, extremely short aortic neck, as well as tight distal aorta.It was reported that during the index procedure the physician prophylactically implanted six aptus endoanchors.The angiogram observed a small proximal type i endoleak and implanted two additional anchors however, the endoleak still persisted.Due to the tight distal aorta the physician gave the patient quite a bit of heparin during the procedure and believes that once the anticoagulation was reversed the type i endoleak would be resolved.In addition, after the procedure was completed, the aptus devices that were used were found to be expired.Both the applier and guide expired on three months ago.No additional clinical sequelae were reported and the patient is fine.

Event Description

Additional information was received.It was reported that a follow up ct showed that the proximal type i endoleak self-resolved.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Type of Device: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5099452
• MDR Text Key: 26849226
• Report Number: 2953200-2015-01620
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• Date Device Manufactured: 05/31/2013
• 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: 00086 YR