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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

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ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM Back to Search Results
Catalog Number 1011915-040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 08/07/2023
Event Type  Injury  
Event Description
Patient id: (b)(6).It was reported that on (b)(6) 2022, three absolute pro stents (6.0x40, 6.0x120, 6.0x80) were implanted in the 100% stenosis in the mildly calcified, proximal left superficial femoral artery (sfa).On (b)(6) 2023, the patient had a persisting stenosis in the index vessel and a persisting pre-existing wound on the index leg.Decision was made to treat these.On (b)(6) 2023, the patient was re-admitted to the hospital.Surgical removal of the calcified stenosis was performed at the femoral bifurcation (index leg) and angioplasty of the sfa (index lesion) was performed.On (b)(6) 2023, a bedside abscess splitting of the persisting wound was performed.The patient condition has resolved.There was no device deficiency.No additional information was provided.
 
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.The reported patient effect of restenosis of stented segment is listed in the absolute pro peripheral self-expanding stent system instructions for use as an adverse event that may be associated with the use of a stent in peripheral arteries and/or biliary tree.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatments appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional absolute pro devices referenced in b5 are filed under separate medwatch report numbers.
 
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Brand Name
ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM
Type of Device
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 Key17638200
MDR Text Key322135927
Report Number2024168-2023-09405
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K072708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 08/28/2023
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? No
Device Operator Health Professional
Device Catalogue Number1011915-040
Device Lot Number2091261
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/22/2023
Initial Date FDA Received08/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age83 YR
Patient SexFemale
Patient Weight38 KG
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