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

Model Number	1012537-60
Medical Device Problem Codes	Material Separation (1562); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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 of the reported lot revealed no similar incidents.The investigation was unable to determine a definitive cause for the reported difficulties.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 performed to treat a non-calcified, non-tortuous right iliac artery.During deployment of the 9.0x60mm absolute pro stent, the thumbwheel would not move after 20% of the stent had been deployed.The stent separated into two pieces as it was attempted to capture the stent in a 6f sheath to remove the entire system.Part of the stent was deployed in the target lesion while the second piece was deployed in the left iliac in healthy tissue.Both portions of the stent were post dilatated then trapped with a non-abbott stent.Per the physician, there was an added 30-40 minutes to the procedure due to the malfunction.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
Na.
Event or Problem Description
Subsequent to filing the final mdr, the following additional information was received: the case was a contralateral approach.The sheath was in the left common femoral artery and the physician was attempting to stent the right iliac.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: 10021068
• Report Number: 2024168-2020-04063
• Device Sequence Number: 3116976
• Product Code: NIP
• UDI-Device Identifier: 08717648176234
• UDI-Public: 08717648176234
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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: 08/31/2021
• Device Model Number: 1012537-60
• Device Catalogue Number: 1012537-60
• Device Lot Number: 8092061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 06/29/2020
• 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: 6F COOK SHEATH; MEDTRONIC STENT
• Outcome Attributed to Adverse Event: Required Intervention