MAUDE Adverse Event Report: COOK INC ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G36144
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Death (1802); Blood Loss (2597); No Code Available (3191)
Date of Event	10/26/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The area representative reported a (b)(6) male patient underwent an endovascular abdominal aortic aneurysm repair (evar) procedure on (b)(6) 2007.During the evar procedure a zenith flex aaa endovascular graft bifurcated main body (catalog number: tffb-32-82) was implanted and the procedure was completed successfully.The patient was in a regular annual follow-up.In the last follow-up, a type ia endoleak was noticed from the tffb-32-82 which is reported using mw:1820334-2017-03782.The physician ordered an zenith renu aaa ancillary graft main body extension (catalog number: rx1-32-62) from cook to resolve the problem.On (b)(6) 2017, the (b)(6) male patient underwent a secondary procedure to repair the proximal type ia endoleak.The physician used a zenith renu aaa ancillary graft main body extension.The patient's vessels were not calcified but were tortuous so the physician used another manufacturer's wire guide instead of a lunderquist wire.[as the back up meyer wires are a little more rigid and provide more support in tortuous vessels].During the secondary procedure, the physician experienced difficulty deploying the rx1-32-62.The physician put the device right in place, withdrew the sheath and the two coated stents opened.Then the first trigger wire was pulled and the screw for the top cap was loosened.However, when the physician wanted to open the top cap, nothing happened.The inner cannula was fixed and was not movable.The physician then pulled the second trigger wire and made a second attempt.Again, he could not move the inner cannula forward.Meanwhile, the stent graft had moved into the descending aorta with the top cap still closed.The physician tried to put a coda balloon in the partially opened stent graft, blocked it and wanted to open the top cap by fixing the stent graft with the coda balloon.This attempt was not successful.Meanwhile the stent graft was now positioned in the height of the aortic arch so that he could open surgically the left subclavian artery and grab the top of the delivery system dilatator.The physician pulled on it to open the bare spring.But when the bare spring was released from the top cap, it still did not open.The single springs held together.He then put in several pta balloons to force the bare spring to open.The stent graft remained in the patient¿s body, the delivery system was retrieved through an intervention from the axillary artery.According to the initial reporter, the patient experienced the following adverse events as a result of this occurrence: prolonged procedure, blood loss, and hospitalization.Additional information was provided on 11/09/2017 that the patient died in intensive care on (b)(6) 2017.Additional information has been requested but not provided regarding the patient's cause of death and the availability of an autopsy report.
Additional Manufacturer Narrative
The patient died after several days on intensive care due to a rupture of the descending aorta, distal entrance of left subclavian artery.The rupture took place right where the zenith renu aaa ancillary graft main body extension had been left.Before the patient suffered from paraplegia in both legs, and a dissection of the descending aorta due to the efforts of removing the top cap and the whole manipulation with balloon catheters to open the bare spring.The patient¿s family refused an autopsy, so there is no official report.The ruptured aorta was proved by ct scan.The physician offered the relatives to do an additional stenting over the rupture, but under the circumstance of a persistent paraplegia of both legs, the family decided against this intervention also in mind, that the patient was in his 80s.Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation/evaluation: a visual inspection and functional testing of the returned device was conducted.In addition, a review of complaint history, the device history record, the instructions for use, manufacturing instructions, quality control data, specifications, and trends was performed.One used device was returned in multiple disassembled pieces.The graft was not returned as it was in the patient.The inner pusher was inside the sheath, the cannula with threaded tip and top-cap was also returned, but was separate from the inner pusher and the pin vise assembly.The cannula had been cut past the pin vise.The trigger wires and collars were returned separate from the device.The tip of the sheath has several small bumps and dents, with scratches along the sheath.A hole is present in the end of the sheath that appears to be from a barb, 14mm from the tip.The inner cannula was able to be reinserted into the grey dilator/pusher without difficulty.Hydrophilic coating was present.The device history record was reviewed for lot 7910294 (finished assembly), sa5562192 (graft) and sa7041603 (subassembly).No non-conformances related to the reported failure mode were noted.Angiography from the zenith renu aaa ancillary graft main body extension (rx-1) implantation computerized tomographic angiography (cta) was provided.An image review was performed based on the imaging provided.The inability to advance the top cap from the suprarenal stent, resulting in rx1 deployment in the thoracic aorta after prolonged procedure is confirmed based on the image review.Per the image review, there was the combined iliac, abdominal and thoracic tortuosity with a mainbody cross leg configuration.This would have prevented the top cap advancement.Per the instructions for use (ifu): vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude the placement of the endovascular graft.Bowing of the metal cannula and wire was noted, indicating the top cap was experiencing significant resistance to advancement.Per the ifu: the (4.5) do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or the delivery system.Inadvertent partial deployment or migration of endoprosthesis may require surgical procedure.The (11.1.4) if resistance is felt or system bowing is noticed, trigger wire is under tension.If unable to remove the black trigger-wire release mechanism from the top-cap, perform the following steps: remove the rigger wire by loosening the pin vise and slightly puling the inner cannula to move the top-cap down over the suprarenal stent.Re-tighten the pin-vise.Remove the black trigger-wire release mechanism.Note: technical assistance from a cook product specialist may be obtained by contacting your local cook representative.If the rx1 remained secured with the 2nd trigger wire, establishment of through and through wire access and additional support from a coda balloon in rx1 would have aided the release, or performing the above trouble shooting steps mentioned in the ifu rather than 2nd trigger wire release (which is not advisable) would have reduced the procedural complication/prolonged procedure.Based on the image review, the rx1 was left perched in an acute thoracic aortic bend located past the subclavian artery origin.Per ifu: the (11.1.2) caution: to avoid any twist in the endovascular graft, be careful to rotate all of the components of the system together.Even after the second trigger wire release, sheath and introducer advancement with coda balloon stabilization would be more preferable rather than displacing the graft into the thoracic aorta.A trend analysis was performed over this failure mode on complaints of all similarly constructed devices, and indicated no negative trend over a three-year period.The ifu lists key anatomic criteria that, if followed, could prevent this failure mode from occurring.Additionally, for this part of the procedure (advancing the top cap), the ifu recommends using an les wire (lunderquist) for extra support and proper placement of the wire within the anatomy during proximal trigger-wire removal.An alternative deployment sequence is detailed within the product ifu, should this failure mode occur and the user needs to use it.Based on the information provided, a definitive root cause for difficulty in releasing the 1st trigger wire could not be determined.The root cause for this complaint is in conclusive.However, based on the image review and information provided by the customer, the patient's tortuous anatomy would have prevented the top cap advancement and difficulty in releasing the trigger wire.Additionally, performing the black trigger-wire release mechanism trouble shooting steps mentioned in the ifu, rather than releasing the second trigger wire, could have reduced the procedural complications and/or the length of the procedure.Per the quality engineering risk assessment, no further action is warranted.The appropriate personnel have been notified of this event.Monitoring will continue to be performed for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.H3 other text : b5: the patient died after several days on intensive care due to a rupture of the descending aorta, distal entrance of left subclavian artery.The rupture took place right where the zenith renu aaa ancillary graft main body extension had been left.Before the patient suffered from paraplegia in both legs, and a dissection of the descending aorta due to the efforts of removing the top cap and the whole manipulation with balloon catheters to open the bare spring.The patient¿s family refused an autopsy, so there is no official report.The ruptured aorta was proved by ct scan.The physician offered the relatives to do an additional stenting over the rupture, but under the circumstance of a persistent paraplegia of both legs, the family decided against this intervention also in mind, that the patient was in his 80s.

• Brand Name: ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7040382
• Report Number: 1820334-2017-03778
• Device Sequence Number: 2037128
• Product Code: MIH
• UDI-Device Identifier: 10827002361444
• UDI-Public: (01)10827002361444(17)190519(10)7910294
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G36144
• Device Catalogue Number: RX1-32-62
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 02/19/2018
• 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; Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 75