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

Catalog Number 1012015-150

Device Problems Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 07/28/2022

Event Type  Injury  

Manufacturer Narrative

The device is returning for analysis; however, device has not been received.A follow-up report will be submitted with all additional relevant information.(b)(4).

Event Description

It was reported that the procedure was to treat a heavily calcified, mildly tortuous distal right common femoral artery that is 70% stenosed.A 6.0x150mm armada 35 balloon dilatation catheter was used for pre-dilatation.The 6x150mm absolute pro was advanced without issue; however, when attempting to deploy the stent the thumbwheel turned with high resistance.More resistance was felt and as the stent was one third deployed the physician felt the device break.The thumbwheel's resistance let up and turned without resistance; however, the stent could not be deployed further.The system was pulled a little harder and the stent either separated into two small parts or was very stretched.The system was removed from the anatomy under fluoroscopy, but the stent was left in the anatomy.Two non-abbott stents were used to embedded the absolute stent.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.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

The device was returned for analysis.The reported activation failure and the reported mechanical jam were unable to be replicated in a testing environment due to the condition of the returned device.The reported stent material separation and the reported stretched were unable to be confirmed as the stent was previously deployed.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, it is possible that the distal shaft was bent in the heavily calcified, mildly tortuous and 70% stenosed anatomy resulting in the noted chatter marks throughout the entire length of the inner member.Preventing the shaft lumens from moving freely, thus resulting in resistance with the thumbwheel and difficulty deploying the stent; however, this could not be confirmed.The investigation determined a conclusive cause for the reported activation failure and mechanical jam cannot be determined.During removal interaction with the anatomy/other devices and/or manipulation of the device possibly resulted in the reported stent material separation and the reported stretched stent; however this could not be confirmed.Manipulation of the device likely resulted in the noted device damages (wrinkled sheath, separated outer member, smashed axil pins).The treatment(s) appears to be related to the operational context of the procedure as reportedly two non-abbott stents were used to embed the absolute stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.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: 15276731
• MDR Text Key: 298411229
• Report Number: 2024168-2022-09052
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012015-150
• Device Lot Number: 2021661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• 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
• Treatment: CORDIS 6F 55 CM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Race: White