MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1012839-40

Device Problems Premature Activation (1484); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 12/19/2022

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that the procedure was to treat the superficial femoral artery with no calcification or tortuosity and 60% stenosis.The 6x40 mm absolute pro self expanding stent system (sess) was advanced to the lesion and attempted to be deployed but the stent could not be released and completely failed to deploy.The sess was removed from the patient and the thumbwheel was pushed very hard to partially deploy [partially exposed, not flowered] the stent outside the patient.Then the sess was placed back into the anatomy and advanced to the lesion and deployed.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported mechanical jam, activation failure and the reported premature activation were unable to be replicated in a testing environment due to the condition of the returned device.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.It is possible that the distal shaft was bent by the anatomy and/or interaction with other devices preventing the shaft lumens from moving freely; thus resulting in reported activation/deployment failure and the reported mechanical jam outside of the anatomy; however this cannot be confirmed.The investigation determined a conclusive cause for the reported activation/deployment failure and the reported mechanical jam cannot be determined.Intentional manipulation of the compromised device outside of the anatomy resulted in the reported premature activation.Reportedly, the 6x40 mm absolute pro self expanding stent system (sess) was advanced to the lesion and attempted to be deployed but the stent could not be released and completely failed to deploy.The sess was removed from the patient and the thumbwheel was pushed very hard to partially deploy [partially exposed, not flowered] the stent outside the patient.Then the sess was placed back into the anatomy and advanced to the lesion and deployed.It should be noted that the absolute pro.035 peripheral self-expanding stent system instructions for use states: this device is intended for single-use only; do not reuse.Additionally, section 6.2 stent placement- precautions states: do not expand the stent if it is not properly positioned in the vessel or bile duct.The reported deviation of the instructions for use does not appear to have caused/contributed to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSOLUTE PRO .035 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: 16122610
• MDR Text Key: 306981591
• Report Number: 2024168-2023-00299
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072708
• 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,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012839-40
• Device Lot Number: 2040661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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: COOK AMPLATZ .035 GUIDE WIRE.