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

Model Number	1012530-80
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.The 8x80 mm absolute pro sess was partially deployed, about 80% however the physician thought it was fully deployed.When the deployment sheath was removed, the stent was pulled back and stretched.The stent was removed via cut down.The patient was released the next day and is doing well.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 similar incidents from this lot.The investigation determined the reported activation/deployment failure appears to be related to circumstances of the procedure as it is likely that the stent was inadvertently not fully deployed/released from the sheath; thus as the deployment sheath was removed, the stent was pulled back and stretched resulting in the reported difficult to remove and the reported stretched stent.As reported, the stent was removed via cut down.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Additional Manufacturer Narrative
The device was not returned for analysis.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 similar incidents from this lot.It is possible that the distal shaft was bent by the anatomy thus preventing the shaft lumens from moving freely; resulting in resistance with the thumbwheel and difficulty deploying the stent; however this cannot be confirmed.The investigation determined a conclusive cause for the reported mechanical jam and activation/deployment failure cannot be determined.As the deployment sheath was removed, the stent was pulled back and stretched resulting in the reported difficult to remove and the reported stretched stent.As reported, the stent was removed via cut down.There is no indication of a product quality issue with respect to manufacture, design or labeling.B5- procedure description was updated.Na.
Event or Problem Description
Subsequent to the initially filed report, it was reported that the thumbwheel may have been jammed.No additional information was provided.

• 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: 16406077
• Report Number: 2024168-2023-01685
• Device Sequence Number: 3327353
• Product Code: NIP
• UDI-Device Identifier: 08717648175725
• UDI-Public: 08717648175725
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/07/2023

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: 10/31/2023
• Device Model Number: 1012530-80
• Device Catalogue Number: 1012530-80
• Device Lot Number: 0111661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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 Sex: Unknown