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	Dyspnea (1816); Respiratory Failure (2484)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: ha-18-114, sn #: unknown, ubd: unknown, udi #: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Heli-fx endoanchors were implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.A non-medtronic (zenith) stent graft system was implanted on the same day.It was reported that 5 days later, the patient was admitted to the hospital for acute exacerbation of copd with respiratory failure.Following a subsequent reintervention procedure on (b)(6) 2019, the patient had acute respiratory failure with hypercapnia.The patient was treated with medication and recovered with treatment.The investigator assessed the event as related to the index / reintervention procedure, not related to the device.It was noted that the acute respiratory failure event was likely linked to sedation for the reintervention.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received reported that the patient's medical history also includes lower extremity peripheral artery disease.Correction: patient weight updated.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: 8873877
• Report Number: 9612164-2019-03283
• Device Sequence Number: 2078923
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 12/18/2020
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0009502482
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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: 87 YR
• Patient Weight: 88