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	Anemia (1706); 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 don the same day.  it was reported that 5 days later, during the hospitalization of the patient for the index procedure and reintervention of the aneurysm, the patient had acute blood loss with anemia and dyspnea.The patient was treated with blood transfusions and recovered with treatment.The investigator assessed the event as related to the index procedure, 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.
Event or Problem Description
The patient also had acute respiratory failure five days after the index procedure, with associated symptoms of dyspnea, altered mental status, and hypercapnia.The event was assessed by the investigator and the sponsor as related to the index procedure, not related to the endoanchors.The patient was treated with medication and the event was resolved.The previously reported acute blood loss with anemia was also assessed by the sponsor as related to the index procedure, not related to the endoanchors.

• 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: 8874115
• Report Number: 9612164-2019-03281
• Device Sequence Number: 16829932
• 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): 08/28/2019

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: 08/28/2019
• 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