ABSORB UNK ABSORB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-26 for ABSORB UNK ABSORB manufactured by Abbott Vascular.

Event Text Entries

[185231182] Date of event - estimated. The unique device identifier (udi) is unknown because the part and lot numbers were not provided. Date of implant - estimated. The devices remain in the patients. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The death, thrombus, myocardial infarction, angina, dyspnea, and occlusion, requiring medication, revascularization and re-hospitalization mentioned are filed under separate mfr numbers. Literature attachment: bioresorbable coronary scaffold thrombosis multicenter comprehensive analysis of clinical presentation mechanisms and predictors.
Patient Sequence No: 1, Text Type: N, H10


[185231183] This is filed to report the device malfunction. It was reported through a research article identifying the absorb bioresorbable vascular scaffold (bvs) that may be related to the following: death, thrombus, myocardial infarction, angina, dyspnea, and occlusion, requiring medication, revascularization and re-hospitalization, and the device malfunction of wall apposition. Details are listed in the attached article, titled bioresorbable coronary scaffold thrombosis multicenter comprehensive analysis of clinical presentation mechanisms and predictors. Please see article for additional information.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03010
MDR Report Key9887133
Report SourceLITERATURE
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2012-05-01
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-26
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 Received2020-03-26
Catalog NumberUNK ABSORB
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
10 2020-03-26

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