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

Catalog Number	1012536-80
Medical Device Problem Codes	Break (1069); Malposition of Device (2616)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion right superficial femoral artery.Pre-dilatation was performed with an unspecified 5.0x100mm balloon catheter.An unspecified absolute pro self-expanding stent system (sess) was being deployed; however, the stent jumped forward 2cm proximal to treatment area.The stent was retracted distally, but the stent fractured and there was residual stenosis after an 8mm balloon angioplasty.An unspecified 8x39mm balloon-expandable stent was placed over the fractured stent and no residual stenosis was demonstrate after placement.There was no adverse patient sequela and no clinically significant delay reported.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.As there was no damage noted to the device during the inspection prior to use, it is possible that during deployment interaction with the anatomy and/or other devices resulted in a build-up of tension within the shaft lumens of the delivery system; thus resulting in a spring like release of the stent resulting in the reported malposition of device (stent jumped forward 2cm proximal to treatment area).Manipulation of the compromised device resulted in the reported stent break; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The treatment(s) appears to be related to the operational context of the procedure as reportedly an unspecified 8x39mm balloon-expandable stent was placed over the fractured stent and no residual stenosis was demonstrate after placement.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: 18013229
• Report Number: 2024168-2023-11889
• Device Sequence Number: 7548640
• Product Code: NIP
• UDI-Device Identifier: 08717648176166
• UDI-Public: 08717648176166
• 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): 02/29/2024

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: 04/30/2026
• Device Catalogue Number: 1012536-80
• Device Lot Number: 3052262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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