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

Model Number	1012535-100
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 75% stenosed, calcified and moderately tortuous vessel in the left iliac artery.The 7.0x100mm absolute pro vascular self-expanding stent system (sess) appeared to have a partially deployed stent once it got out of the sheath and into the artery.The sess was removed and another absolute pro vascular sess was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure was able to be confirmed.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 did not indicate a lot specific quality issue.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 during advancement inadvertent mishandling and/or interaction with other devices resulted in the noted device damages (wrinkled, torn, separated distal sheath) and thus ultimately resulting in the reported activation failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 13930389
• Report Number: 2024168-2022-03239
• Device Sequence Number: 6309992
• Product Code: NIP
• UDI-Device Identifier: 08717648176098
• UDI-Public: 08717648176098
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/02/2022

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: 03/31/2023
• Device Model Number: 1012535-100
• Device Catalogue Number: 1012535-100
• Device Lot Number: 0040161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.35 STORQ GUIDE WIRE
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 67 KG