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

Catalog Number 1012838-80

Device Problems Premature Activation (1484); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the superficial femoral artery with no tortuosity.The 5.0x80 mm absolute pro self expanding stent system (sess) was advanced to the lesion but the stent could not be released but it was flowered.The thumbwheel could not be rotated.Additionally, the stent still could not be released outside the anatomy after withdrawal.Another same size absolute pro sess was used to complete the procedure.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 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.

Event Description

It was reported that the procedure was to treat the superficial femoral artery with no tortuosity.The 5.0x80 mm absolute pro self expanding stent system (sess) was advanced to the lesion but the stent could not be released but it was flowered.The thumbwheel could not be rotated.Additionally, the stent still could not be released outside the anatomy after withdrawal.Another same size absolute pro sess was used to complete the procedure.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.Analysis of the returned device found that the stent was exposed for a length of 6mm from the distal end of the outer sheath confirming the reported activation failure.An attempt was made to rotate the thumbwheel, but the thumbwheel would not rotate, confirming the reported mechanical jam.A review of the lot history record for the reported lot revealed no associated nonconforming material records or exceptions.A query of the complaint handling database for the reported lot revealed no other incidents.It is possible that the distal shaft was bent by the anatomy preventing the shaft lumens from moving freely, resulting in resistance with the thumbwheel and difficulty deploying the stent; however this cannot be confirmed.Procedural contaminants (dried blood) likely contributed to the confirmed difficulties with the compromised returned unit.The investigation was unable to determine a conclusive cause for the reported/noted difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6 medical device problem code updated 1484 to 3270.

• 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: 15841213
• MDR Text Key: 306993621
• Report Number: 2024168-2022-11827
• 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: 01/06/2023

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: 1012838-80
• Device Lot Number: 1122061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2021
• 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: SUPRA CORE GUIDE WIRE