MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Model Number	1235250-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The scaffold remains implanted in the patient.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 effects of restenosis, as listed in the absorb gt1 instructions for use (ifu), is a known patient effect that may be associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, 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 design, manufacture or labeling of the device.
Event or Problem Description
Patient id: (b)(4).It was reported that this was a coronary procedure, performed on (b)(6) 2017, to treat a lesion in the distal circumflex artery.The 2.5 x 12 mm absorb gt1 was implanted without issue.On (b)(6) 2018, coronary angiography was performed and noted in-stent restenosis of 25-50%.The study physician deemed the restenosis as not significant and no intervention was performed.Approximately 2.5 years post procedure, routine coronary angiography noted that the restenosis was now 75%.The patient was asymptomatic and no intervention was performed.The patient condition continues.No additional information was provided.
Event or Problem Description
Subsequent to the initial/final mdr report, additional information was provided.The patient was re-hospitalized on (b)(6) 2020 for follow up coronary angiography.The patient experienced no symptoms and coronary angiography was performed on (b)(6) 2020.The restenosis in the distal circumflex was noted to be 90%; however, no intervention was performed at that time.On (b)(6) 2021, coronary intervention was performed.Pre-dilatation was performed using a non-abbott dilatation catheter and 2.25 x 20 mm non-abbott stent was implanted.The patient was discharged to hope on (b)(6) 2021.No additional information was provided.
Additional Manufacturer Narrative
Based on the information reviewed, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.B2: outcomes attributed to ae.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9988790
• Report Number: 2024168-2020-03849
• Device Sequence Number: 17117738
• Product Code: PNY
• UDI-Device Identifier: 08717648212949
• UDI-Public: 08717648212949
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2018
• Device Model Number: 1235250-12
• Device Catalogue Number: 1235250-12
• Device Lot Number: 6100761
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 78 YR
• Patient Weight: 48