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	Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	11/29/2016
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.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot numbers were not provided.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.The reported patient effects of ischemia, myocardial infarction and thrombosis, 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 information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure on (b)(6) 2016 was to treat a proximal/ostial and mid left anterior descending (lad) artery.The patient was turned down for coronary artery bypass surgery.It is unknown what device was used for pre-dilatation; however, the residual stenosis was reduced to less than 40%.A 3.0 x 12 mm xience alpine stent was deployed in the proximal ostial lad and a 2.5 x 28 mm absorb scaffold was implanted in the mid lad.Post dilatation was performed with a 2.75 balloon catheter, the final angiographic residual stenosis was less than 10%.Optical coherence tomography (oct) confirmed the final vessel size was 2.2 mm at the distal edge and then stepped down to 1.9 mm.Oct also confirmed the stent and scaffold were fully apposed to the vessel wall.On (b)(6) 2016 the patient presented with a st elevated myocardial infarction and electrocardiogram showed anterolateral wall ischemia.Additionally, thrombosis was confirmed in the mid-portion of the absorb scaffold.A guide wire was advanced and a 2.5 x 15 mm non-abbott balloon catheter was used to dilate the lesion.A 2.75 x 12 mm xience alpine stent was implanted in the mid-portion of the absorb to the distal edge of the scaffold.Post-dilatation was performed with a 2.75 x 8 mm unspecified nc balloon catheter.Testing confirmed the patient was either not compliant with dual antiplatelet therapy or is a non-responder.The patient was changed from plavix to ticagrelor.The patient is in stable condition.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: 6168350
• Report Number: 2024168-2016-08813
• Device Sequence Number: 131319
• Product Code: PNY
• UDI-Device Identifier: 08717648212987
• UDI-Public: (01)08717648212987
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 12/12/2016

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 Catalogue Number: 1235250-28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.0 X 12 MM XIENCE ALPINE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 70 YR