MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ABSOLUTE PRO; STENT, ILIAC

Model Number	1012537-80
Medical Device Problem Codes	Stretched (1601); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.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 the distal shaft was bent in the 80% stenosed anatomy resulting in preventing the shaft lumens from moving freely; thus resulting in the reported activation/deployment failure.Manipulation of the compromised device as the device was being pulled back resulted in the reported stretched stent.The treatment(s) appears to be related to the operational context of the procedure.Based on the reported information and results of the complaint investigation 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 left external iliac artery with 80% stenosis.A 7x60 mm armada percutaneous transluminal angioplasty (pta) catheter was used for angioplasty and then the 9x80 mm absolute pro self expanding stent system (sess) was advanced to the lesion and deployed.During deployment, the stent partially deployed and was above the lesion, so the stent was pulled.This stretched the stent into the common femoral artery (cfa) and part remained in the target lesion.Right common femoral access was obtained and the stent was ballooned with a 6x40 mm armada pta catheter.Then a laser was used in the proximal and mid superficial femoral artery (sfa).The 6x40 mm armada was used to achieve hemostasis on the left cfa in order to treat the sfa as the long sheath needed to be removed from the left cfa to be placed in the right cfa.There was no hemorrhage.The armada balloons functioned as intended without issue.A non-abbott 7x150 mm stent was deployed in the external iliac artery.There were no adverse patient sequela.No additional information was provided.

• Brand Name: ABSOLUTE PRO
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20192473
• Report Number: 2024168-2024-10684
• Device Sequence Number: 6815771
• Product Code: NIO
• UDI-Device Identifier: 08717648176241
• UDI-Public: (01)08717648176241(17)260131(10)3020661
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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: 01/31/2026
• Device Model Number: 1012537-80
• Device Catalogue Number: 1012537-80
• Device Lot Number: 3020661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CORDIS .035 GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 76 KG