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-36-161

Device Problems Material Rupture (1546); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Expiration date: unknown as lot # is unknown.Mfr date unknown as lot # is unknown.Investigation is still in progress.(b)(4).

Event Description

Description of event according to initial reporter: during the deployment of the sheath there was a lot of friction and the sheath started to squeeze and the hydrophilic coating shrank up.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Lot#: unknown as information was not provided.Expiration date: unknown as lot# is unknown.(b)(4).Summary of investigational findings: the investigation of this complaint was based on the information available and examination of the returned product.Imaging of patient anatomy was requested, but not provided.Imaging would be helpful in determine whether patient anatomy affected deployment in this case.As per ifu certain anatomic elements may result in difficulty when withdrawing the sheath.Also, it was requested why the sheath appeared compressed, when the complaint concerns deployment issues.It may be presumed that the user would try to withdraw the sheath, not advance it.According to an email from the sales rep., the product was used off-label, as the user was aware that the anatomy was out of ifu.Based on the investigational results and in accordance with "medical device reporting for manufacturers - section 2.6", it has been determined that the event is non-reportable, as the event was solely the result of off-label use of the device by the user, with no other performance issue and no device-related death and/or serious injury occured.

Event Description

Description of event according to initial reporter: during the deployment of the sheath there was a lot of friction and the sheath started to squeeze and the hydrophilic coating shrank up.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6101606
• MDR Text Key: 59892767
• Report Number: 3002808486-2016-01397
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P140016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZTA-P-36-161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/27/2016
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1