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

Catalog Number 1012015-150

Device Problems Entrapment of Device (1212); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a 60% stenosed lesion in the superficial femoral artery (sfa) with moderate calcification.A 6fr sheath was used.After post-dilatation with a 4x200mm and 5x200mm non-abbott balloons, the 5x150mm absolute pro self expanding stent system (sess) was advance to the target lesion and the stent was attempted to be released; however, after 6cm has deployed the thumbwheel became stuck.Therefore, the handle of the sess was opened to attempt to manually deploy the stent, but failed.The sheath in the procedure was used to encapsulate the sess and after some time the sess was removed from the patient.There was no adverse patient sequela and no clinically significant delay reported in the procedure.The procedure was completed with a non-abbott stent.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 was unable to be replicated in a testing environment as it was based on operational circumstances.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database 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 the distal shaft was bent in the moderately calcified and 60% stenosed anatomy resulting in preventing the shaft lumens from moving freely; thus resulting in the reported mechanical jam and the reported activation/deployment failure.Manipulation of the device resulted in the noted multiple device damages (sporadically wrinkled sheath, separated sheath, bunched inner member, separated outer member, broken spool pegs) likely contributing to the reported difficulties.Manipulation of the handle in an attempt to manually deploy the stent resulted in the noted handle damages (handle gap, separated strain relief, sporadically smashed stabilizer, loose ribbon, knot noted on the ribbon).As reported the sheath was used to encapsulate the sess and after some time the sess was removed from the patient resulting in the noted bent/stretched stent.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 19074207
• MDR Text Key: 339776407
• Report Number: 2024168-2024-04473
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648130212
• UDI-Public: (01)08717648130212(17)250731(10)2082362
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• 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: 2082362
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2022
• 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: 6 FR COOK 55CM FLEXOR CHECK FLO SHEATH.; COMMAND ST 0.18 300CM GUIDEWIRE.
• Patient Outcome(s): Required Intervention