MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1012014-150

Device Problems Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/26/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the moderately calcified left common femoral artery.A contralateral approach was taken with a non-abbott 7fr 45 cm sheath and the lesion was pre-dilated with a 5x100 mm armada percutaneous transluminal angioplasty (pta) catheter.The 5x150 mm absolute pro self expanding stent system (sess) was advanced and deployment was initiated.After about 4 cm of release it was not possible to release any more of the stent as the deployment system was stuck.Several maneuvers were attempted, including disconnection of the catheter release system, but without success.The physician opted for advancing the long introducer to the closest one to the stent, and the stent was withdrawn partially deployed.When the sess was removed it caused friction in the intima and the patient's final state was reported as "injury".A new 5x120 mm absolute pro stent was implanted to complete the procedure.Reversal of heparin was performed at the end of the procedure to reduce the possibility of hematoma at the puncture site.There was a delay in the procedure but no harm reported.Final patient outcome is good per control arteriography.No additional information was provided.

Manufacturer Narrative

A visual and functional analysis was performed on the returned device.The reported deployment difficulties and mechanical jam of the thumbwheel could not functionally be confirmed due to the condition of the returned unit.However, the condition of the returned unit is consistent with the reported difficulties encountered.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no indication of a lot specific product quality issue.The reported patient effect of injury to artery (rupture, perforation, dissection) is listed in the absolute pro ll instruction for use as a known possible complication that may occur with use of the device.The investigation was unable to determine a definitive cause for the reported deployment difficulties resulting in tissue injury, unexpected medical intervention, and treatment with medications.It is possible that the shaft was bent or entrapped within the anatomy (possibly at the aortic bifurcation, which was described as ¿quite accentuated¿) preventing movement of the shaft lumens causing the thumbwheel to lock up preventing further deployment.Continued force applied in the attempt to rotate the thumbwheel likely placed excessive tension on the ribbon causing the outer member to separate preventing any further transmission between the thumbwheel and distal sheath.However, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the original report, on may 11th, 2022, abbott determined that a field safety notice was required for the absolute pro ll peripheral self-expanding stent system (psess).Abbott has confirmed reports of mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent.To reduce occurrences of deployment failures and associated outcomes, abbott is notifying all users of the potential causes and risks.

Manufacturer Narrative

Although the difficulties encountered appear to be related to procedural circumstances, on may 11th, 2022, abbott determined that a field safety notice (fsn) was required for the absolute pro ll peripheral self-expanding stent system (psess).Abbott has confirmed reports of mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent.To reduce occurrences of deployment failures and associated outcomes, abbott is notifying all users of the potential causes and risks.H6: investigation conclusions code 4315 removed; 4307 added.

• Brand Name: ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13020580
• MDR Text Key: 285696645
• Report Number: 2024168-2021-11703
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 1012014-150
• Device Lot Number: 0012361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• 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
• Treatment: AQUALINER 0.035 INCH 260 CM GUIDE WIRE; DESTINATION 7FR 45CM SHEATH
• Patient Outcome(s): Disability; Required Intervention