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

Catalog Number 1012014-150

Device Problems Entrapment of Device (1212); Device Damaged by Another Device (2915); Mechanical Jam (2983); Activation Failure (3270)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

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.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.

Event Description

It was reported that the procedure was to treat the popliteal artery.The patient has a history of chronic occlusion of the superficial femoral artery.The 5x150 mm absolute pro self expanding stent system (sess) was advanced to the lesion and deployment was attempted.After one centimeter had been deployed, deployment was blocked as the deployment mechanism would not operate.The sess could also not be withdrawn so transversion was performed to remove the stent and sess.During removal of the stent and delivery system, a previously implanted stent was displaced and additional surgery was performed to remove the stent.The target lesion was treated with two additional stents.Another procedure was performed on (b)(6) 2022 due to a groin hematoma and the patient remained hospitalized.The groin hematoma was probably due to the removal of the cross sheath which caused trauma to the artery.The hematoma was treated with incision and draining on (b)(6) 2022.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported mechanical jam and the reported activation failure were unable to be replicated in a testing environment due to the condition of the returned device.The reported entrapment of device and the reported device damaged by another device were unable to be replicated in a testing environment as it was based on operational circumstances.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 did not indicate a lot specific quality issue.It is possible that interaction with the anatomy/other devices and/or inadvertent mishandling resulted in the noted device damages (bunched distal sheath, kinked/cracked outer member jacket, multiple smashed strain relief) thus preventing the shaft lumens from moving freely and thus resulting in the reported mechanical jam and the reported activation/deployment failure; however this cannot be confirmed.The investigation determined a conclusive cause for the reported mechanical jam and the reported activation/deployment failure cannot be determined.The noted device damages (torn/twisted ribbon, separated inner member, stretched/flared/deformed stent) likely occurred due to inadvertent mishandling during/post procedure or during packing for return analysis.The treatment appears to be related to the operational context of the procedure as during removal of the stent and delivery system a previously implanted stent was displaced resulting in the reported entrapment of device, the reported device damaged by another and additional surgery was performed to remove the 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 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: health effect clinical code 4582 removed; 4559 added.Health effect impact code 4641 removed; 4624 added.Medical device problem code 2915 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: 15065397
• MDR Text Key: 296228808
• Report Number: 2024168-2022-07927
• 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: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012014-150
• Device Lot Number: 1112261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2021
• 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: HT COMMAND 18
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White