MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 TAA ENDOVASCULAR GRAFT DISTAL COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G53480
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/30/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).Bd4) catalog# zteg-2d-36-136-pf-us.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.(b)(4).Investigation is still in progress.
Event or Problem Description
"description" of event according to initial reporter: "phone call from physician mid procedure.Stated distal bare stent did not deploy upon sliding down of #2 trigger release mechanism.He stated he removed trigger wire number 1 and followed by releasing and sliding back the distal bare spring deployment mechanism which clicked in to place.He then removed the #3 trigger wire.It wasn¿t until after the #3 trigger wire was removed that he noticed on the fluoro screen that the distal bare stent of the distal thoracic graft was only halfway deployed with half of the stent remaining in the bottom cap.He could not further deploy the bare stent as the #2 slide mechanism was already clicked in to place.Pulling the entire sheath and grey positioner down as one did not release the bare spring.Ultimately he had to resheath the bare stent bottom cap and push and rotate the gray positioner which finally freed the bare stent and allowed it to fully deploy." additional information received 07sep2017: "the patient came in with a ruptured thoracic aneurysm and from speaking with physician lost too much blood despite them finishing the procedure which was the cause of death." patient outcome: additional information received 01sep2017: the dm confirmed that the patient died post procedure.
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.Summary of investigational findings: this complaint concerns deployment difficulties as the distal bare stent of the distal thoracic graft was only halfway deployed with half of the stent remaining in the bottom cap.Examination of the returned product showed one small mark was seen on the tip of the sheat.Microscopic evaluation of the inside of the bottom cap showed small, thin scratches near the hole of the bottom cap.According to complaint history this is most likely the result of the device being deployed in an angled anatomy.Imaging and additional information regarding patient anatomy was requested but not provided to support investigation.According to the description of event the patient came in with a ruptured thoracic aneurysm and lost too much blood causing patient death despite finishing the procedure.Therefore, the reported patient death is most likely not procedure or product related.As per ifu the safety and effectiveness of device has not been evaluated in patient populations with leaking, pending rupture or ruptured aneurysm.No evidence to suggest that the device was not manufactured according to specification.Cook medical will continue to monitor for similar events.

• Brand Name: ZENITH TX2 TAA ENDOVASCULAR GRAFT DISTAL COMPONENT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6881842
• Report Number: 3002808486-2017-01847
• Device Sequence Number: 718259
• Product Code: MIH
• UDI-Device Identifier: 10827002534800
• UDI-Public: (01)10827002534800(17)170903(10)E3251411
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P070016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G53480
• Device Catalogue Number: ZTEG-2D-36-136-PF-US
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/31/2017
• Device Age: 36 MO
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 12/14/2017
• 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: Death