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

Catalog Number 1012017-120

Device Problems Material Separation (1562); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/23/2022

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 an iliac vein.The lesion was pre-dilated.An 8x120mm absolute pro ll was advanced and when deployment was initiated, there was resistance when advancing the thumbwheel forward to deploy.At that moment about 1.5cm of the stent was placed/deployed and the thumbwheel restricted (no movement), therefore no possibility to further deploy.A retrograde puncture was performed.The introducer was placed and it was possible to steer the initial guide wire into the introducer placed at the retrograde puncture side.A pullback of the absolute pro ll was performed/ at that moment the stent implant broke in two pieces in the vessel and the delivery system was removed outside of the patient.A covered stent was placed through the introducer made at the retrograde puncture side.The covered stent was deployed as intended embedding the absolute pro ll stent in the vessel wall.No additional information was provided.Subsequent to the original assessment, on (b)(6) 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.Subsequent to the original assessment, on (b)(6) 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

The device was returned for analysis.The reported stent material separation was able to be confirmed.The reported activation/deployment failure and the reported mechanical jam were unable to be replicated in a testing environment due to the condition of the returned device.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 identified no other incidents from this lot.As there was no reported damage noted to the device during the inspection prior to use, the investigation determined that the reported difficulties were likely related to circumstances of the procedure as it is likely that interaction with the anatomy and/or other devices resulted in restricting the shaft lumens from moving freely thus resulting in the reported mechanical jam and the reported activation/deployment failure.Manipulation of the device to remove resulted in the noted device damages (multiple bent/stretched stent struts, separated outer member from the distal end of the shuttle).The treatment(s) appears to be related to the operational context of the procedure as a retrograde puncture was performed.A covered stent was placed through the introducer made at the retrograde puncture side.The covered stent was deployed as intended embedding the absolute pro ll stent in the vessel wall.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.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.

• 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: 14651272
• MDR Text Key: 294163484
• Report Number: 2024168-2022-06224
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012017-120
• Device Lot Number: 1081361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• 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: 0.035 GUIDE WIRE
• Patient Outcome(s): Required Intervention