ABSORB 1235250-18

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for ABSORB 1235250-18 manufactured by Abbott Vascular.

Event Text Entries

[187870221] There was no reported device malfunction and the product was not returned. 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 stenosis, as listed in the absorb gt1 instructions for use (ifu), is a known adverse event associated with the use of a coronary scaffold in native coronary arteries. A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10


[187870222] Patient id (b)(6). It was reported that on (b)(6) 2017, the patient underwent a coronary procedure performed to treat a lesion in the distal circumflex artery. A 2. 5 x 18 mm absorb gt1 bioresorbable vascular scaffold (bvs) was implanted. On (b)(6) 2020, a new area of stenosis, within 5 mm from the previously implanted absorb scaffold, was noted. On (b)(6) 2020, the patient was re-hospitalized and a revascularization procedure was performed, resolving the event. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-02828
MDR Report Key9875793
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-02-05
Date Mfgr Received2020-02-28
Device Manufacturer Date2016-10-04
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 2024168
Manufacturer Street26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal Code925914628
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABSORB
Generic NameBIORESORBABLE SCAFFOLD
Product CodePNY
Date Received2020-03-24
Model Number1235250-18
Catalog Number1235250-18
Lot Number6100461
Device Expiration Date2018-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-24

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