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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD
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ABBOTT VASCULAR ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD Back to Search Results
Model Number 1235300-18
Device Problem Material Deformation (2976)
Patient Problems Ischemia (1942); Stenosis (2263)
Event Date 07/06/2018
Event Type  Injury  
Manufacturer Narrative
The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.
 
Event Description
Patient id: (b)(6).It was reported that on (b)(6) 2017, a percutaneous coronary intervention (pci) was performed on the distal right coronary artery (rca) lesion.Following pre-dilatation, a 3.0x18mm absorb gt1 scaffold (1235300-18, 6100461) was successfully implanted in the distal rca.On (b)(6) 2017, another pci was performed.Following pre-dilatation, a 3.0x23mm absorb scaffold (1235300-23, 6101161) was successfully implanted in the 1st diagonal coronary artery.There were no adverse events and there was no device malfunction.On (b)(6) 2020, the patient was hospitalized.A coronary angiogram was performed and silent myocardial ischemia diagnosed.The distal rca, 3.0x18mm absorb scaffold, was observed with restenosis and a flared strut.As treatment, an atherectomy was performed.The event resolved without sequela.There was no restenosis and no device issue regarding the 1st diagonal, 3.0x23mm absorb scaffold.No additional information was provided regarding this issue.
 
Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.It should be noted that the reported patient effects of ischemia and restenosis as listed in the bioresorbable vascular scaffold system, absorb, instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.The investigation was unable to determine a conclusive cause for the reported difficulties.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.B6:(b)(6)2019 : coronary angiogram removed and replaced with the correct year, (b)(6)2017.
 
Event Description
Subsequent to the previous medwatch report, the additional information was obtained: this patient event was also captured in a published article titled " overhanging bioresorbable vascular scaffold observed on angioscopy 1 year after implantation¿ it was reported through a research article that the 3.0x18mm absorb gt1 scaffold was implanted without a device issue.Per optical coherence tomography, the scaffold was completely embedded in the vascular endothelium.12 months later and per imaging, there was no restenosis, however, there was discontinuity of the bvs and some struts apart from the vessel.Torn struts overhanging into the vascular lumen, remaining stationary on the endothelium and resistant to coronary blood flow were also observed.During a follow-up catheriization, the vessel wall of the proximal site of the overhanging bvs showed positive remodeling and there were no attached struts.The physicians speculate that prompt positive remodeling caused early dislodgement and scheduled degeneration of the dislodged struts causing them to roll up and fall onto the distal side.Dual antiplatelet therapy was provided without any adverse events for 2 years after pci.Details are found in the attached article: ¿overhanging bioresorbable vascular scaffold observed on angioscopy 1 year after implantation¿.
 
Manufacturer Narrative
The device remained implanted and is not returning for analysis.The investigation is not yet complete.A follow-up report will be submitted reporting additional, relevant information.Literature attached: ¿overhanging bioresorbable vascular scaffold observed on angioscopy 1 year after implantation¿b3: estimated date.The article reports a new date of occurrence as one year following the index procedure which was performed on (b)(6)2017.The date of occurrence has been estimated as (b)(6)2018.
 
Event Description
Subsequent to the previous medwatch report, the additional information was obtained: (b)(6)2018 discontinuity of the bvs and some struts apart from the vessel were observed.
 
Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the information reviewed, a conclusive cause for the reported difficulties and patient effects could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.B3: actual date of event.
 
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Brand Name
ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
Type of Device
BIORESORBABLE SCAFFOLD
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key10179822
MDR Text Key196074605
Report Number2024168-2020-05209
Device Sequence Number1
Product Code PNY
UDI-Device Identifier08717648213045
UDI-Public08717648213045
Combination Product (y/n)Y
PMA/PMN Number
P150023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 12/22/2020
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
Device Operator Health Professional
Device Expiration Date04/01/2018
Device Model Number1235300-18
Device Catalogue Number1235300-18
Device Lot Number6100461
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/29/2020
Initial Date FDA Received06/22/2020
Supplement Dates Manufacturer Received08/31/2020
11/02/2020
12/15/2020
Supplement Dates FDA Received09/04/2020
11/19/2020
12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
1 IMPLANTED ABSORB SCAFFOLD.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age77 YR
Patient Weight62
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