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

Catalog Number	1235300-18
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	10/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other device referenced is being filed under a separate medwatch report.
Event or Problem Description
It was reported that on (b)(6) 2016, the patient underwent a coronary procedure, with implantation of an unspecified xience stent in the circumflex artery and two 3.0 x 18 mm absorb bioresorbable vascular scaffold (bvs) in the mid right coronary artery (rca).On (b)(6) 2016, the patient presented to the emergency room with angina and thrombus was noted within the absorb bvs.Optical coherence tomography (oct) was performed and the scaffold was noted to be well apposed to the vessel wall.Balloon angioplasty was performed using an nc trek dilatation catheter.There was some concern that the patient was either non-compliant with plavix therapy or was resistant to plavix; therefore, the patient's medication was changed to brilinta.Post procedure, the patient is doing well and the thrombus is resolved.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Correction: date of event.The device was not returned for evaluation.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 angina 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.A cine was received and reviewed by an abbott vascular clinical specialist who concluded that the angiogram shows moderate calcium burden throughout the vessel and heavy in focal areas.The images confirm post-dilatation of the implanted scaffolds with good result, but there is a residual 50% stenosis in the rca, distal to the second scaffold in a heavily calcified untreated area.Additionally, the images confirm thrombosis in the proximal and mid right coronary artery.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 and there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Subsequent to initial 30-day medical device report, it was noted that the patient presented to the emergency room and was admitted on (b)(6) 2016.Balloon angioplasty was performed on (b)(6) 2016.There was no additional information 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: 6094085
• Report Number: 2024168-2016-07850
• Device Sequence Number: 958914
• Product Code: PNY
• UDI-Device Identifier: 08717648213045
• UDI-Public: (01)08717648213045(17)170510(10)6051161
• 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,Followup
• Report Date (Section B): 03/21/2017

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: 05/10/2017
• Device Catalogue Number: 1235300-18
• Device Lot Number: 6051161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Supplement Report FDA Received Date: 03/21/2017
• 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: THE 3.0X18MM ABSORB GT1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention