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

Model Number	1012536-30
Medical Device Problem Codes	Entrapment of Device (1212); Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported malposition, migration and entrapment in the vessel were unable to be confirmed/tested as the stent had already been fully deployed and was not returned.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 complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the distal sheath was restricted or entrapped within the anatomy causing the stent to "jump" during deployment due to built-up tension within the shaft lumens of the delivery system resulting in a spring like release of the stent; however, this could not be confirmed.The migration may have occurred during the attempt to snare the stent resulting in the stent migrating into the left pulmonary.The additional treatment, foreign body in patient and delay in procedure appear to be due to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a left av fistula.An absolute pro self-expanding stent system (sess) was advanced to the lesion; however, upon turning the wheel to deploy the stent, the stent flowered and jumped out.An attempt was made to snare the stent, but the stent migrated into the left pulmonary and became lodged there.Another same sized absolute stent was used to successfully treat the lesion.The patient will be transferred to surgery to remove the foreign body in the left pulmonary.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
• MDR Report Key: 10621532
• Report Number: 2024168-2020-08229
• Device Sequence Number: 14386412
• Product Code: NIP
• UDI-Device Identifier: 08717648176135
• UDI-Public: 08717648176135
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2020

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: 06/30/2023
• Device Model Number: 1012536-30
• Device Catalogue Number: 1012536-30
• Device Lot Number: 0072861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .035 HYDROSTEER WIRE
• Outcome Attributed to Adverse Event: Required Intervention