MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT BALLOON; CATHETER, PERCUTANEOUS

Model Number AB46

Device Problem Device Damaged by Another Device (2915)

Patient Problem Injury (2348)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant stent graft system was implanted for the endovascular treatment of a 55mm abdominal aortic aneurysm.Final angiogram showed an endoleak, thought to be a type ii endoleak.It was reported that the day after the index procedure, the patient became circulatory unstable.A ct performed showed a ruptured aneurysm.The stent graft system was partially explanted, undamaged, and a large tear was found in the graft.The graft tears are in the ipsilateral leg and are dorsal as the mainbody was implanted from the right side.The stent graft was replaced with a dacron stent graft.As per the physician the cause of the event was due to product failure or damage during the implantation or during the ballooning of the graft.The stent graft had been fully ballooned with a reliant balloon and it was noted that the ballooning at the flow divider was excessive.No additional clinical sequela were reported and the patient is fine.

Manufacturer Narrative

Films review summary: the cause of the aaa rupture could not be determined from the pre-implant films provided.Lack of images during implant and ct¿s po st-implant did not allow for review of the implant procedure or assessment of the stent graft in-vivo configuration post-implant.Review of a returned pre-implant ct film report revealed that the patient had a long proximal neck ranging in diameter from 21 ¿ 22mm along a 50mm length.The common iliac arteries were moderately calcified bilaterally.The rcia ranged in diameter from 11 ¿ 12mm along a 67mm length, and the lcia ranged in diameter from 12 ¿ 13mm along a 78mm length.From the information currently provided, it appears most likely that the cause of the aaa rupture was from the reported large type iii fabric endoleak likely occurring at implant in an area of the bifurcate ipsilateral limb where the ballooning was performed.The cause of the balloon potentially tearing the fabric is currently unknown; however, the ballooning was reported as ¿excessive¿ near the level of the flow divider.Analysis of the returned films did not reveal any obvious anatomical characteristics that could explain reported event.The proximal neck was long with no appreciable calcification observed; however lack of 3d reconstruction and transverse neck and aaa slice images did not allow for a thorough assessment of any localized calcification or potential neck/vessel angulation that may have been present, and that potentially may have contributed to the fabric tear occurring during ballooning.In addition, the location of the stent graft tear relative to the patient¿s anatomy is also currently unknown.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Film review summary: the cause of the aaa rupture could not be determined from the films provided.Images during implant were not available for review, and assessment of the ballooning and endoleak reported at implant could not be performed.Pre-implant films revealed that the proximal neck along the 5cm neck length measured ~22mm in diameter, with scattered calcification and thrombus present.At the bottom of the neck the aortic diameter narrowed down to ~18 x 20mm, and the aorta was acutely angulated ~80 deg rt-lt with an area of calcification seen along the inner curve of this angulation.Post-implant images showed that the bifurcate was positioned ~5mm below the renal arteries, the proximal od measured ~24mm, and the aortic body and infrarenal neck were angulated ~50 deg a-p x 45 deg rt-lt.The maximum diameter aaa measured ~50mm with widespread contrast seen within the aaa beginning ~30mm below the renals.The aaa appeared to have ruptured at the top of the aaa and possibly included the distal portion of the proximal neck.The exact source of the endoleak could not be determined but appeared most likely to have been a type iii fabric endoleak coming from near the flow divider region of the bifurcate.Since this location was reportedly in an area where excessive ballooning was performed, it appears most likely that the endoleak was caused by over-inflation of the balloon utilized during the initial implant.This tear was most likely the same endoleak source seen during implant that was initially thought to have been a type ii.It is unclear if the severely angulated proximal neck observed pre-implant may have also contributed to the rupture.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction to date of event: (b)(6)2018.Correction to return date (initial mdr):10-may-2018.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIANT BALLOON
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7543984
• MDR Text Key: 109224258
• Report Number: 2953200-2018-00762
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2020
• Device Model Number: AB46
• Device Catalogue Number: AB46
• Device Lot Number: 0008958246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR