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

Catalog Number 1011916-060

Device Problems Material Separation (1562); Difficult to Advance (2920)

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

Event Date 01/09/2024

Event Type  malfunction  

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 the superficial left femoral artery.After pre-dilatation with an unknown device the 7.0x60mm absolute pro self-expanding stent was successfully implanted.Post dilatation was performed and all the devices were removed from the anatomy.It was observed a small part of the absolute sheath (4 or 5 cm) was present at the distal end of the 6fr introducer, after removal of the device.It is unknown when the separation occurred; however, it may have occurred when the unspecified balloon was advanced for post-dilatation as some resistance was felt.No separated portion of the device remained in the anatomy.There was no adverse patient effects reported and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to advance was 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.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 after the stent was successfully implanted during device removal interaction with the 6fr introducer and/or inadvertent mishandling resulted in the reported/noted sheath separation.During post-dilatation interaction between the separated sheath material and the unspecified balloon device resulted in the reported difficult to advance.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: 18628374
• MDR Text Key: 334375302
• Report Number: 2024168-2024-01338
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072708
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011916-060
• Device Lot Number: 3080261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• 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 Age: 67 YR