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

Model Number	1012528-80
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.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 this was a procedure to treat the mid superficial femoral artery (sfa) with heavy calcification.The 6.0x80 mm absolute pro self expanding stent system (sess) device was advanced; however resistance was met with the anatomy.Then prior to reaching the target lesion, it was observed that the stent was flowered.The stent was coming out of the sheath.Therefore, the physician removed the device from the patient without issue.Balloon angioplasty was performed.Then a 5.5x120 mm supera sess was advancing, but could not cross the target lesion due to anatomical challenges as well.Therefore the device was removed without issue.Additional ballooning was performed to open up the calcification.The supera sess was re-advanced, but still could not cross the target lesion due to the anatomy.Therefore, the supera sess was removed again without issue and the procedure was aborted.This caused a delay and the patient was suffering from back pain from laying down so long.The issues advancing both devices took several hours which is why the patient had back pain.The patient was transferred to the post op room and the back pain subsided on its own.The patient is stable and was discharged without additional treatment.The target lesion was never treated.No other information was provided.
Additional Manufacturer Narrative
Visual and functional evaluation was performed on the returned device.The premature deployment was confirmed as the device was returned with the stent partially deployed and flowered.The failure to advance was not tested as it was based on procedural circumstances.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.The investigation determined that the reported difficulties were due to circumstances of the procedure.Based on the reported information and evaluation of the returned unit, the resistance noted during advancement was the result of challenging anatomical conditions.In addition, it is likely that during the attempt to advance against resistance, the distal sheath became kinked causing the sheath to move distally resulting in partial deployment.The reported patient back pain as a result of laying down so long was due to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.D4: part number, udi corrected.

• 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: 12339083
• Report Number: 2024168-2021-07281
• Device Sequence Number: 4686830
• Product Code: NIP
• UDI-Device Identifier: 08717648175565
• UDI-Public: 08717648175565
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 01/31/2024
• Device Model Number: 1012528-80
• Device Catalogue Number: 1012534-80
• Device Lot Number: 1021161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR