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

Model Number 1012534-100

Device Problems Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a heavily calcified cto lesion located in left mid-superficial femoral artery to trifurcation using right cfa access, up and over a 7 fr 45 cm destination sheath.The absolute pro self-expanding stent system (sess) was advanced to the lesion without any resistance; however, during the deployment, the thumbwheel stopped working and the sess was partially deployed.The sess with the partly deployed stent was simply withdrawn from the patient¿s anatomy without any issues or damage to the artery.No intervention was required.There was no adverse patient effect and no reported clinically significant delay in the procedure.Another absolute pro stent was successfully deployed to treat the target lesion.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported activation/deployment failure was able to be confirmed.The reported mechanical jam was able to be confirmed.Additionally, it was noted that the outer member separated and there were broken stent struts.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 in the heavily calcified anatomy and/or interaction with other devices resulted in preventing the shaft lumens from moving freely 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 difficulties cannot be determined.Manipulation of the device likely resulted in the noted device damage (separated outer member) and ultimately resulted in the noted separated and broken stent struts.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 14439621
• MDR Text Key: 292193898
• Report Number: 2024168-2022-05382
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176012
• UDI-Public: 08717648176012
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012534-100
• Device Catalogue Number: 1012534-100
• Device Lot Number: 1092461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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: 260CM 035 BENTSON WIRE; 7 FR 45 CM DESTINATION SHEATH