MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	ZTA-P-34-113-W
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: this patient returned with two weeks with infected graft and ultimately underwent explant and open thoraco-abdominal repair.No signs 1st of infection on her 1st presentation but given timing assuming that her initial rupture was due to infection.Additional information received 09sep2016: this was a ruptured aneurysm patient that presented with symptoms.The alpha device was used and they had a great inter operative result.Additional information received 12sep2016: patient admitted to the hospital on (b)(6) 2016 with back pain, fever, and elevated wbc; blood cultures + for strep pyogenes.Explant occurred (b)(6) 2016, sent to microbiology - cultures did not grow anything.After the explant, rifampin soaked dacron graft placed.Patient outcome: discharged after long postoperative course at home; has a periaortic fluid collection managed with drain, last seen during brief admission for drain exchange and is on long term antibiotics (currently on daptomycin for 6 weeks).
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: based on the provided imaging, it was possible to confirm the existence of mycotic aneurysm.The aneurysm likely was infected on the (b)(6) 2016 cta as the aneurysm was not excluded on this scan.A review of the ifu indicates that the stent graft is supplied sterile to the user facility.The user is also advised to minimize handling of the constrained endoprosthesis during preparation and insertion to decrease the risk of endoprosthesis contamination and infection.Lastly, the ifu lists infection amongst the list of potential complications that are "possible adverse events¿.No evidence to suggest that the device was not manufactured according to specifications cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to initial reporter: this patient returned with two weeks with infected graft and ultimately underwent explant and open thoraco-abdominal repair.No signs 1st of infection on her 1st presentation but given timing assuming that her initial rupture was due to infection.Additional information received 09sep2016: this was a ruptured aneurysm patient that presented with symptoms.The alpha device was used and they had a great inter operative result.Additional information received 12sep2016: patient admitted to the hospital on (b)(6) 2016 with back pain, fever, and elevated wbc; blood cultures + for strep pyogenes.Explant occurred (b)(6) 2016, sent to microbiology - cultures did not grow anything.After the explant, rifampin soaked dacron graft placed.Patient outcome: discharged after long postoperative course at home; has a periaortic fluid collection managed with drain, last seen during brief admission for drain exchange and is on long term antibiotics (currently on daptomycin for 6 weeks).
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: based on the provided imaging, it was possible to confirm the existence of mycotic aneurysm.The aneurysm likely was infected on the (b)(6) 2016 cta as the aneurysm was not excluded on this scan.A review of the ifu indicates that the stent graft is supplied sterile to the user facility.The user is also advised to minimize handling of the constrained endoprosthesis during preparation and insertion to decrease the risk of endoprosthesis contamination and infection.Lastly, the ifu lists infection amongst the list of potential complications that are "possible adverse events¿.No evidence to suggest that the device was not manufactured according to specifications cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to initial reporter: this patient returned with two weeks with infected graft and ultimately underwent explant and open thoraco-abdominal repair.No signs 1st of infection on her 1st presentation but given timing assuming that her initial rupture was due to infection.Additional information received 09sep2016: this was a ruptured aneurysm patient that presented with symptoms.The alpha device was used and they had a great inter operative result.Additional information received 12sep2016: patient admitted to the hospital on (b)(6) 2016 with back pain, fever, and elevated wbc; blood cultures + for strep pyogenes.Explant occurred (b)(6) 2016, sent to microbiology - cultures did not grow anything.After the explant, rifampin soaked dacron graft placed.Patient outcome: discharged after long postoperative course at home; has a periaortic fluid collection managed with drain, last seen during brief admission for drain exchange and is on long term antibiotics (currently on daptomycin for 6 weeks).

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 5979122
• Report Number: 3002808486-2016-01111
• Device Sequence Number: 19233151
• Product Code: MIH
• UDI-Device Identifier: 10827002353494
• UDI-Public: (01)10827002353494(17)190413(10)E3438638
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2016

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 Catalogue Number: ZTA-P-34-113-W
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/07/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/27/2016
• Supplement Report FDA Received Date: 02/15/2017; 03/09/2017
• 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: Life Threatening
• Patient Age: 61 YR