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); Thrombosis (2100)
Date of Event	10/03/2016
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.The reported patient effects of angina and thrombosis as listed in the absorb gt1 instructions for use is a known adverse event 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 lot could not be conducted because the lot number was not provided.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The two 2.5 x 28 mm absorb gt1 devices referenced are being filed under separate medwatch reports.
Event or Problem Description
It was reported the patient presented to the emergency room with a st elevation myocardial infarction (stemi) on (b)(6) 2016.Intravascular ultrasound was performed prior to implantation of three absorb gt1 scaffolds, a 3.0 x 12 mm in the mid circumflex (cx) and two 2.5 x 28 mm overlapping in the mid left anterior descending (lad) coronary artery.The circumflex was pre-dilated with a 3.0 x 12 mm nc trek balloon and post-dilatation was done with a 3.5 x 12 mm nc trek.The mid lad was pre-dilated with a 2.5 x 20 mm nc trek balloon and post-dilatation was done successfully with a 3.0 x 15 mm nc trek balloon.The patient presented with chest pain in the emergency room on (b)(6) 2016 and angiography revealed 100% thrombus in all of the scaffolds.Reportedly, the patient had not been dual antiplatelet therapy (dapt) compliant since the scaffolds had been implanted.A balloon pump was used and thrombus aspiration was done; however, there was too much thrombus; therefore, the patient was then sent for coronary artery bypass graft (cabg).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: 6042604
• Report Number: 2024168-2016-07109
• Device Sequence Number: 13808112
• 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
• Report Date (Section B): 10/19/2016

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: 1235300-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2016
• Initial Report FDA Received Date: 10/19/2016
• 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: SCAFFOLD: ABSORB GT1 2.5 X 28 MM (X2)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 91