MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number	1235250-23
Health Effect - Clinical Codes	Angina (1710); Cardiac Enzyme Elevation (1838); Stenosis (2263)
Date of Event	04/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The reported patient effects of angina and restenosis, as listed in the absorb gt1 instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, a conclusive cause for the reported patient effects, 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
It was reported that the procedure on (b)(6) 2017 was to treat a 67% stenosed, non-tortuous, and non-calcified lesion in the mid left anterior descending artery.The patient presented with heart failure and unstable angina.Optical coherence tomography (oct) was used throughout the procedure.The vessel was determined to be greater than 2.5 mm.Pre-dilatation was performed with a nc trek balloon catheter at nominal pressure.The residual stenosis was reduced to less than 40%.A 2.5x23mm absorb gt1 scaffold was implanted.Post-dilatation was performed with a nc trek balloon dilatation catheter.The final angiographic residual stenosis was less than 10%.Oct confirmed that the scaffold was fully apposed to the vessel wall.The patient was compliant in following the dual antiplatelet therapy (dapt) of clopidogrel after the procedure.The patient was readmitted to the hospital on (b)(6) 2017 with chest pain and elevated levels of troponin.An oct was performed and confirmed restenosis in the previously implanted scaffold.The restenosis was treated with laser atherectomy and a 2.5x28mm xience alpine stent was implanted.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6558756
• Report Number: 2024168-2017-04046
• Device Sequence Number: 134086
• Product Code: PNY
• UDI-Device Identifier: 08717648212970
• UDI-Public: (01)08717648212970
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1235250-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 05/11/2017
• 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