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

Catalog Number	1235250-28
Health Effect - Clinical Codes	Occlusion (1984); Thrombosis (2100)
Date of Event	12/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of occlusion and thrombosis, as listed in the absorb gt1 instructions for use (ifu), are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, 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 patient presented with chronic stable angina.The index procedure on (b)(6) 2016 was to treat a lesion located in the mid left anterior descending (lad) artery at the junction of the lad bifurcation and diagonal.No disease in the diagonal.Quantitative coronary angiography determined the vessel diameter to be 2.75mm.Predilatation was performed using a semi-compliant balloon at high pressure with residual stenosis reduced to less than 20%.A 2.5x28mm absorb gt1 was implanted; however, there was no flow through the diagonal.A guide wire was advanced to dilate the diagonal which got the flow back but needed a small stent in place distal to the absorb gt1 in the lad.The scaffold and stent should not be in contact; therefore, they were not overlapped.After succeeding with the diagonal stenting, the lad at the absorb gt1 site thrombosed locally in the scaffold.A 2.75x15mm nc non-abbott balloon catheter was used to reinflate the scaffold at 18 atmospheres and it was a success angiographically.The final angiographic residual stenosis was less than 10%.The cardiologist believes that he should have monitored the act level more closely as it was below 200 and it could have been the cause of the peri procedural thrombosis in the scaffold.The patient was placed on ticagrelor post thrombosis.No additional information was provided.

• 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: 6227449
• Report Number: 2024168-2017-00146
• Device Sequence Number: 976418
• Product Code: PNY
• UDI-Device Identifier: 08717648212987
• UDI-Public: (01)08717648212987(17)170408(10)6040961
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2017
• Device Catalogue Number: 1235250-28
• Device Lot Number: 6040961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/05/2017
• 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: Required Intervention