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

Model Number	1012535-60
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the procedure was to treat a lesion in the calcified left common iliac artery.When attempting to deploy the 7.0x60mmx135cm absolute pro self-expanding stent system (sess), resistance was felt with the thumbwheel.Fluoroscopy confirmed, the stent was not deploying, confirmed it had not flowered either.The decision was made to remove the absolute pro, when retracting the system from the sheath, the device got caught on the hemostatic valve of the sheath and the stent was pulled out and is stuck in the valve of the sheath.A new sheath and a non-abbott stent were used to complete the procedure.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported mechanical jam was able to be confirmed.The reported activation failure and the reported difficult to remove were unable to be replicated in a testing environment due to the condition of the retuned 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 reported 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 inadvertent mishandling and/or interaction with the anatomy/other devices resulted in the noted device damages (wrinkled inner member, wrinkled sheath, sheath chatter marks, multiple jacket stabilizer and outer member bends, smashed tip) thus preventing the shaft lumens from moving freely resulting in the reported mechanical jam and the reported activation/deployment failure.Further manipulation/mishandling likely resulted in the noted gear on top of the thumbwheel.Interaction with the hemostatic valve during removal resulted in the noted stent damages (stretched, bent, deformed, separated).There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 14299214
• Report Number: 2024168-2022-04894
• Device Sequence Number: 17523842
• Product Code: NIP
• UDI-Device Identifier: 08717648176074
• UDI-Public: 08717648176074
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/15/2022

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: 01/31/2025
• Device Model Number: 1012535-60
• Device Catalogue Number: 1012535-60
• Device Lot Number: 2021461
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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
• Patient Sex: Unknown