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

Catalog Number 1012009-150

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

Patient Problem Foreign Body In Patient (2687)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional absolute pro ll device referenced in b5 is filed under separate medwatch report number.

Event Description

It was reported that the procedure was to treat a heavily calcified, heavily tortuous iliacal bifurcation.An unknown absolute pro stent only partially deployed as the thumbwheel would not turn further.The handle was taken apart in attempt to deploy the stent however, failed.During removal it was noted that the tip separated.The tip remained in the anatomy and was not removed.A second unknown absolute pro stent was also partially deployed and noted to have the same exact issue.The stent was partially deployed as the thumbwheel would not turn further.When removing the device the tip separated.The tip remains in the patient.There was no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported activation failure and the reported mechanical jam was unable to be replicated in a testing environment due to the condition of the returned device.The reported material separation was unable to be confirmed as the stent was not returned.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 damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the heavily calcified, heavily tortuous anatomy and very high acute angle on the bifurcation resulted in the noted device damages (bent/kinked/smashed stent sheath, sheath drag marks) preventing the shaft lumens from moving freely; thus resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent.Manipulation of the compromised device in attempts to deploy the stent resulted in the noted separated/torn outer member and exposed inner braiding and the noted smashed spool axle.The noted multiple bends and kinks throughout the jacket stabilizer and the outer member likely occurred due to handling contributing to the reported difficulties and/or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.A cine was received and reviewed by an abbott vascular clinical specialist.Heavily calcified and tortuous iliac artery was targeted to be treated by absolute pro stent system.It was reported that the absolute pro was only partially deployed as the thumbwheel would no longer turn.The physician opted to dismantle the handle to deploy stent, resulting in a failure of deployment.A tip separation of the device upon removal under fluoroscopy occurred afterwards, where the tip was then left in the anatomy.A second absolute pro was inserted and attempted to deliver the stent, where the second stent was also partially deployed as it¿s thumbwheel was also unable to turn any further.The physician attempted to remove the second absolute pro under fluoroscopy where the tip separated and left in the anatomy.The complaint included three fluoroscopic images of a heavily calcified and tortuous anatomy, where it shows partially deployed stents within the anatomy.The images cannot confirm which media represented which absolute pro device included in this complaint.While the media does confirm that partial deployments did occur, it does not indicate the probable cause of the event.B5 - describe event - updated.

Event Description

Subsequently, after the initial report was filed, it was confirmed per device analysis that the 6.0x150mm on 80cm was the absolute pro that the handle was taken apart.The 6.0x150mm on 135cm is the second absolute pro and both delivery systems were removed under fluoroscopy.It was noted no treatment was provided to remove the separated portion.No additional information was provided.

• 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: 18581677
• MDR Text Key: 333745026
• Report Number: 2024168-2024-01106
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012009-150
• Device Lot Number: 3082161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2023
• 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): Required Intervention; Other