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

Catalog Number 1012015-150

Device Problems Stretched (1601); Difficult or Delayed Activation (2577)

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

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported partial stent deployment and stent stretching were unable to be confirmed due to the condition of the returned unit and the stent had been fully deployed and was not returned.Additionally, it was noted that the outer member was separated from the shuttle.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 complaints reported from this lot.The investigation was unable to determine a cause for the reported deployment difficulties resulting in stent stretching and subsequent unexpected medical intervention.It may be possible that the distal shaft was kinked or entrapped within the anatomy (possibly at the aortic bifurcation) preventing movement of the shaft lumens and allowing only partial stent deployment.Continued force applied in the attempt to rotate the thumbwheel likely placed excessive tension on the outer member causing it to separate from the shuttle, as noted.Once the outer member separation occurred transmission between the thumbwheel and distal sheath was lost preventing further stent deployment.The reported stretching of the stent likely occurred due to movement of the stent system during manipulation of the system to fully complete the stent deployment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a moderately calcified lesion in the superficial femoral artery (sfa).A 6x150mm absolute pro ll self-expanding stent (ses) was advanced to the target lesion and deployment was initiated when the delivery system ¿broke¿ and the stent was only partially deployed.The handle was disassembled to push and implant the stent into the sfa.The stent was stretched to approximately double in length.A second absolute pro was implanted in the first stent to successfully complete the procedure.There was no additional information 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: 12558302
• MDR Text Key: 274229565
• Report Number: 2024168-2021-08785
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2021

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 1012015-150
• Device Lot Number: 1011361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2021
• 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
• Patient Outcome(s): Required Intervention