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

Catalog Number	1235300-12
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	12/22/2016
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.(b)(4).The device was not returned for evaluation.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, myocardial infarction 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.It should be noted that the absorb gt1, ifu states: it is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon or lesion with greater than 40% residual stenosis after pre-dilatation by visual estimation.The reported wall apposition, patient effects and treatment appears to be related to the circumstances of the procedure.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 index procedure on (b)(6) 2016 was to treat a lesion located in the proximal left anterior descending (lad) artery with heavy calcification.The vessel was determined to be 3.0mm in diameter per angiography.Predilatation was performed with a 3.0 x 12 mm nc trek balloon catheter; however, residual stenosis was greater than 40%.A 3.0 x 12 mm absorb scaffold was implanted and post-dilatation was performed with a 3.0 x 12 mm nc trek balloon.No images were taken to determine whether the absorb scaffold was fully apposed to the vessel wall.The patient presented emergently on (b)(6) 2016 with chest pain and was admitted.Angiography showed an st segment elevation myocardial infarction (stemi) and thromobsis/fully occluded scaffold in the proximal lad artery.A 3.5 x 15 mm xience alpine was implanted and flow was restored; patient doing fine.The patient was confirmed to have been compliant with their dual anti-platelet therapy (dapt) consisting of plavix after the procedure.There have been no changes to the patient's dapt.Reportedly, review of the procedure cine by the account rep identified that the absorb scaffold was not well apposed to the vessel wall.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Removed the following verbiage from the evaluation: it should be noted that the absorb gt1, ifu states: it is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon or lesion with greater than 40% residual stenosis after pre-dilatation by visual estimation.

• 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: 6332862
• Report Number: 2024168-2017-01221
• Device Sequence Number: 16399422
• Product Code: PNY
• UDI-Device Identifier: 08717648213021
• UDI-Public: (01)08717648213021
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/07/2017

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: 1235300-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2017
• Supplement Report FDA Received Date: 03/07/2017
• 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; Disability