MAUDE Adverse Event Report: COVIDIEN ABRE VENOUS SELF-EXPANDING STENT SYSTEM; STENT, ILIAC VEIN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 03/01/2022

Event Type  Injury  

Event Description

Physician was attempting to use the abre stent during procedure.Overall procedure took roughly 35-45 minutes to complete.Pre-procedural imaging is unknown.General anesthesia was administered.Physician access in posterior tibial vein on the right.The right external iliac vein was occluded or 99% stenotic.Collaterals noted around stenosis, these were not huge collaterals seen in chronic occlusion.Physician felt that it was subacute disease, 6-8 weeks, and that tracked back to the time of onset of symptoms.Physician noted that the guidewire used crossed the lesion easily.Physician exchanged for a stiff wire.Physician access accessed in the juglar vein with stiff wire down to iliacs as a preventative measure to catch a stent if it migrated.Physician used ivus for the procedure.A 14 mm balloon was used for predilation, then stent with a 14mm diameter stent, and then post-dilated with a 14 mm balloon.One abre stent was deployed in the ivc and in iliacs.Abre extended into iliac veins.Procedure went as expected and patient was sent to pacu for recovery, where the patient then became hypotensive.Ct performed and showed ascited with suggestion of bleed in ascites with extravasation noted.Hemoglobin dropped a full gram and act was almost.Physician took patient back and accessed via jugular vein.Physician performed venogram and did lateral/oblique veins that showed bleeding at the level of the mid-body of the abre stent.Physician noted that the stent was placed in a curve, but not at an extreme curve.It was noted that it appeared one of the peaks appeared to be outside of the eiv.It was reported that one of the abre stents allegedly caused perforatation.Physician relined stent with a non-medtronic (gore) 16 mm diameter limb of a graft.Physician acknowledged that the patient's surgery previously was very complicated and there a lot of surgical clips in the area.Patient was reported to be fine with no other reported issues.No further injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: patient presented in (b)(6) 2022 with symptoms of right leg swelling and scrotal edema as well as redness to right leg.No confirmed dvt at that time.Unclear if patient was taking avastin for cancer (usually recommended to stop this prior to surgery).The right external iliac vein was occluded or 99% stenotic.Patient was hydrated with iv fluids.The stent was placed in a curve but not extreme curve.There was no unusual presentation.There was nothin unusual with delivery of stent and no excessive force used.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image analysis:audio analysis: three videos were provided for evaluation.Video one march post opp: the physician is talking through the angiogram in english.He gets rj access and brings the catheter down and does dedicated imaging of the pelvis.You can see the first contrast injection.The stent is widely patent.There is free flow in the ivc.The stent is on a curve.He didn¿t see if immediately as there was a lot of bowel in the areas but there is a small bleed at the end of the abre stent.He placed a covered stent across the entire segment.Physician followed up with patient and he is doing very well and swelling is gone down.Video 2: physician again talking over video in english.This video is images of the ct scan after the patient became hypotensive.The patient has a stent there already and you cant tell mu ch more from the images.Video 3: physician a talks over video in english.Video is a right lower extremity venogram.An occlusion can be seen, a wire and catheter can easily access the proximal common iliac.You can see images of the pelvic area.A non-medtronic balloon is used to do gentle angioplasic.A 14 x 120 abre is placed.The ivus images after the procedure shows everything looks very good.Normal lumen to normal lumen.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ABRE VENOUS SELF-EXPANDING STENT SYSTEM
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13791582
• MDR Text Key: 289256413
• Report Number: 9612164-2022-01051
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• 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): Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male