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

Model Number	1012535-80
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Difficult to Advance (2920); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with diminished blood flow and the procedure was to treat a 70% stenosed lesion in the let external iliac artery with moderate calcification and moderate tortuosity.Using the crossover approach, the 7x80mm abs pro vascular self expanding stent system (sess) was advanced to the target lesion with resistance due to the anatomy.During deployment of the stent the thumbwheel was difficult to turn and when the stent had been halfway released the thumbwheel stopped turning.Therefore, the physician opened the handle to removed the wheel in the handle and manually completely release the stent.Blood flow improved; however, was remained diminished due to poor artery wall stent apposition.Therefor, an absolute pro stent was deployed for better wall apposition of the stent.Flow was restored to the left external iliac artery.There was no adverse patient sequela.The procedure was completed with a perclose prostyle clip to close the access site.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult to advance was unable to be replicated in a testing environment as it was based on operational circumstances.The reported mechanical jam and the reported difficult or delayed activation were unable to be replicated in a testing environment due to the condition of the returned device.Electronic lot history record (lhr) 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.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 resistance was met with the moderately calcified, moderately tortuous and 70% stenosed anatomy resulting in the reported difficult to advance.Interaction and/or manipulation of the device resulted in the noted device damages (kinked tip jacket, wrinkled sheath, bent/wrinkled outer member) thus resulting in preventing the shaft lumens from moving freely; thus resulting in the reported mechanical jam.Manipulation of the compromised device in attempts to deploy the stent by opening the handle to manually completely release the stent resulted in the noted tip jacket separation and the noted sheath separation.As reported, an absolute pro stent was deployed for better wall apposition of the stent.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.D1 correction: brand name updated.D2a correction: common device name updated.D3 correction: name, address updated.

• 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: 19512255
• Report Number: 2024168-2024-06910
• Device Sequence Number: 11617545
• Product Code: NIO
• UDI-Device Identifier: 08717648176081
• UDI-Public: (01)08717648176081(17)250930(10)2102461
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 1012535-80
• Device Catalogue Number: 1012535-80
• Device Lot Number: 2102461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 93 KG