MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ABSOLUTE PRO; STENT, ILIAC

Model Number	1012535-80
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in the description of incident is filed under a separate report number.
Event or Problem Description
It was reported the procedure was to treat the left external illiac artery with heavy calcification and heavy tortuosity.The 7x80mm absolute pro self expanding stent was advanced over a 0.035 hi-torque versacore floppy guide wire without resistance.The thumbwheel was engaged and the stent deployed without issues.Upon withdrawal, resistance was felt with the guide wire.Saline was flushed through the absolute pro delivery system using the hydroplane technique, in order to slide the absolute pro delivery system off the guide wire.The guide wire was removed and proximal portion of the wire was noted to be bent yet remained intact.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult to remove was unable to be replicated in a testing environment due to the condition of the returned device.The reported break was able to be confirmed.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 incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified and heavily torturous anatomy resulting in the reported difficult to remove.Interaction/manipulation of the device resulted in the noted devices damages (inner member/stent holder kinked, distal sheath sporadically bunched/wrinkled, outer jacket bunched) and the noted guide wire damages; likely contributing to the reported difficult to remove over the guide wire.As reported, the stent holder separated during withdrawal outside the body likely due to inadvertent mishandling.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.Additional information: b5: describe event - updated.H6: medical device problem code 1069 added.
Event or Problem Description
It was reported the procedure was to treat the left external illiac artery with heavy calcification and heavy tortuosity.The 7x80mm absolute pro self expanding stent was advanced over a 0.035 hi-torque versacore floppy guide wire without resistance.The thumbwheel was engaged and the stent deployed without issues.Upon withdrawal, resistance was felt with the guide wire.Saline was flushed through the absolute pro delivery system using the hydroplane technique, in order to slide the absolute pro delivery system off the guide wire.The guide wire was removed and proximal portion of the wire was noted to be bent yet remained intact.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed mdr report, it was reported that during withdrawal the shaft of the stent delivery system broke outside the anatomy.No additional information was provided.

• Brand Name: ABSOLUTE PRO
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19690911
• Report Number: 2024168-2024-08017
• Device Sequence Number: 15205206
• Product Code: NIO
• UDI-Device Identifier: 08717648176081
• UDI-Public: (01)08717648176081(17)250331(10)2042261
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 08/07/2024

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: 03/31/2025
• Device Model Number: 1012535-80
• Device Catalogue Number: 1012535-80
• Device Lot Number: 2042261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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: 0.035 HI-TORQUE VERSACORE FLOPPY GUIDE WIRE
• Patient Sex: Unknown