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

Model Number	1012538-100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/28/2021
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 identified no other similar incidents and/or complaints reported from this lot.Based on the information provided, a definitive cause for the reported stent fracture and vessel perforation resulting in medical intervention could not be determined.It may be possible that when post-dilatation was performed, the stent was over-expanded causing stent fracture and vessel perforation; however, this could not be confirmed.The additional medical intervention was related 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 the superficial femoral artery with tibial access on the right leg.There was moderate calcification and no tortuosity noted.Laser atherectomy was performed and a non-abbott stent was deployed proximally with no issues noted.The 10x100 mm absolute pro vascular self expanding stent (ses) was then deployed distally with no issues noted.Post-dilatation was performed with a 6.0x40 mm unspecified balloon.During post-dilatation, a perforation in the mid portion of the absolute pro vascular ses was discovered and intravascular ultrasound (ivus) confirmed a stent fracture in the same location as the perforation.Access was gained via right common antegrade fashion with an 8fr sheath placed and a non-abbott covered stent was used to treat the perforation and stent fracture.There were no adverse patient sequela.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: 11856681
• Report Number: 2024168-2021-04257
• Device Sequence Number: 11498054
• Product Code: NIP
• UDI-Device Identifier: 08717648176319
• UDI-Public: 08717648176319
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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: 04/30/2023
• Device Model Number: 1012538-100
• Device Catalogue Number: 1012538-100
• Device Lot Number: 0051361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/20/2021
• 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: 6.0X40 UNSPECIFIED BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 77