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

Model Number	G35344
Medical Device Problem Codes	Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
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).Name and address for importer site:.(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: "this was the second graft that was going to be implanted in the patient as this was a 2 piece case.Two thoracic components were going to be used.The first deployed just fine with no issues.This first one deployed thru a 18fr delivery system.The second device was a 16fr sheath and the physician was advancing it thru the first sheath (an 18fr sheath).However during this process the 16fr sheath got stuck and would not advance or come back.Everything was removed from the patient at this time.On the surgical table with quite some effort they were able to pull off the 18fr sheath from the 16fr sheath.When pulled off, the 16fr sheath became damaged.The16fr looks like the braiding on the sheath got stretched and shredded the plastic of the sheath.The physician did not want to reinsert as the sharp edges may have caused damage to the patient's anatomy.It was decided to open a new device to complete the procedure." patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Investigation is still in progress.
Event or Problem Description
Clarification of description of event received 22aug2017: yes some of this information is incorrect.The second device was not delivered through the sheath of the first device, rather it was delivered through a new, short 30cm 18fr cook introducer.The reasoning for going trough an 18fr introducer included the fact that we had percutaneous access and we would be dropping two french sizes when delivering the second component.The physician wanted to minimize bleeding around the smaller sheath, so we decided to keep it an 18 fr.Which was the same french size as the first device implanted.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Manufacturer ref# (b)(4).Summary of investigational findings: the reported information in this complaint file states failure related to device advancement.By report, the complaint device was delivered through a short 30cm 18fr cook introducer.The alpha device got stuck and was unable to either be advanced or pulled back.Everything was removed from the patient at this point.The inner diameter of the used sheath was not provided.Multiple attempts were made to obtain the rpn of the used cook introducer but failed to obtain it.The device, that was returned in this case was visually inspected and scanned fluoroscopically.In addition, the device was deployed under fluoroscopy without difficult.The device examination did not found evidence suggesting a manufacturing outside of specification or a device failure.In addition to examination of returned product, review of the lot-specific device history record (dhr) was conducted.Review of the dhr for this product did not reveal any evidence that the product was manufactured outside of specification.A definitive root cause could not be determined.The inner size of the applied sheath was not provided why it cannot be determined if the use of the outer sheath contributed to the reported difficulty.Advancement of the zenith alpha introduction system through an outer sheath has not been formally tested.Cook will reopen its investigation if further information is received.Cook medical will continue to monitor for similar events.

• 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; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6803123
• Report Number: 3002808486-2017-01642
• Device Sequence Number: 1038752
• Product Code: MIH
• UDI-Device Identifier: 10827002353449
• UDI-Public: (01)10827002353449(17)200626(10)E3599201
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• 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,Followup
• Report Date (Section B): 01/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G35344
• Device Catalogue Number: ZTA-P-30-201-W
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/28/2017
• Device Age: 1 MO
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 08/22/2017; 12/21/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 09/11/2017; 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1