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

Model Number	SA-85
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: sa-85, serial/lot #: (b)(4), ubd: 06-oct-2019, udi#: (b)(4) ; product id: sg-64, serial/lot #: unknown, ubd: unknown, udi#: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis bifurcated stent graft system was in a patient for the endovascular treatment of a 72mm abdominal aortic aneurysm.Seven heli-fx endoanchors were also deployed during the procedure.It was reported that two days later the patient had urinary retention with symptoms of suprapubic pressure and bilateral inguinal pain.A foley catheter was placed to treat the patient and the event is resolved.The investigator assessed the event as probably related to the index procedure and unlikely related to a device.The sponsor assessed the event to have a casual relationship to the procedure and was not related to the endoanchors.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8721465
• Report Number: 9612164-2019-02462
• Device Sequence Number: 2221158
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2019
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0008826013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 108