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

Catalog Number	1012536-40
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right iliac artery with mild calcification and mild tortuosity.Approach was through the radial artery using a 6f (french) sheath.The 8.0x40mm absolute pro vascular self-expanding stent system (sess) had no resistance during advancement and was attempted to be positioned in the target lesion when the 6f sheath tip appeared to be causing issues with advancement.The physician noted that she was having issues with this sheath throughout the case.It was then decided to retract the absolute pro without force and the stent remained intact but the outer covering of the sess sheath still connected to the device; however, detached from the base.The devices were removed together as a single unit as there was resistance during removal with the 6f sheath.The stent was deemed unusable at that point and was successfully removed from the patient intact.Another stent through the new right groin access and a non-abbott closure device completed the procedure.There was no adverse patient effect and although there was a moderate delay in the procedure; there was no patient harm.No additional information was provided.
Additional Manufacturer Narrative
The device not returned for analysis.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other similar 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 during device withdrawal interaction with the 6f sheath/guiding catheter resulted in the reported difficult to remove.Interaction/manipulation of the device ultimately resulted in the reported break.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: 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: 19160205
• Report Number: 2024168-2024-04982
• Device Sequence Number: 12750038
• Product Code: NIP
• UDI-Device Identifier: 08717648176142
• UDI-Public: (01)08717648176142(17)250531(10)2062161
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 1012536-40
• Device Lot Number: 2062161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F SHEATH
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White