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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Angina (1710); Myocardial Infarction (1969); Occlusion (1984); No Information (3190)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.The additional absorb device is being filed under separate medwatch reports.

Event Description

It was reported that two unknown absorb scaffolds were implanted in the left anterior descending artery (lad) and one in the right coronary artery (rca) more than 2.5 years ago.The patient was re-admitted after two years with angina and evagination.Re-vascularization with an unknown drug-eluting stent was performed in the lad.The patient was compliant using dual antiplatelet therapy.At the next follow-up, the evagination in the rca was gone.No additional information was provided.

Event Description

Subsequent to the previously filed report, the following additional information was received from the site and via an article titled: "coronary artery aneurysm with thrombosis after implantation of a bioresorbable coronary artery scaffold".The patient presented with a non-st-segment elevation myocardial infarction (nstemi) in 2016.Three unspecified absorb scaffolds were deployed; two in the left coronary artery and one in the right coronary artery.On (b)(6) 2017, the patient was re-hospitalized with another nstemi.An angiogram confirmed that all three stents were occluded.It was confirmed through optical coherence tomography that one stent had thrombus, adhering the aneurysmal wall and thought to be the source of distal embolization that resulted in an nstemi.A non-abbott stent graft was deployed in the left coronary artery to treat the occlusion.The right coronary artery was not treated as it was noted that the occlusion was not thrombus but instead evagination.On (b)(6) 2018, the non-abbott stent graft was occluded and a 2.5x38mm and 2.75x23mm xience drug eluting stents were deployed to treat the occlusion.No additional information was provided.

Manufacturer Narrative

Patient codes: 1708 labeled 1984 labeled 1969 labeled.(b)(4).Udi#: in the absence of a reported part number, the udi cannot be calculated.Date of event, therapy dates - corrected.Removed patient code 3190.The incident information was reviewed; however, there was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.The reported patient effects of aneurysm, angina, myocardial infarction and occlusion, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use is known adverse events associated with the use of a coronary scaffold in native coronary arteries.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot number was not provided.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.Literature : coronary artery aneurysm with thrombosis after implantation of a bioresorbable coronary artery scaffold.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7704800
• MDR Text Key: 114534529
• Report Number: 2024168-2018-05643
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCAFFOLD: (ABSORB X 2)
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 33 YR