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

Catalog Number	1235350-18
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Stenosis (2263)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).There was no reported device malfunction and the product was not returned as it remains implanted.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, dyspnea and restenosis, 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.A conclusive cause for the reported patient effects and the relationship to the product, if any, could not be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.Voluntary medwatch report number mw5075563.(b)(4).
Event or Problem Description
Voluntary medwatch report (mw5075563) was received and states: in 2017, i had the abbott gt1 bvs absorb stent placed in my heart, after 9 months the stent failed.I started getting chest pain and shortness of breath.I had to be restented on 2018.Additional information received: in addition to experiencing chest pain and shortness of breath, the patient failed a stress test and was hospitalized.A computed axial tomography (cat) scan and an angiography were performed, revealing a 95% occlusion of the scaffold.A 3.0 x 33 mm xience alpine stent was implanted as treatment.There was no reported adverse patient sequela.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: 7383115
• Report Number: 2024168-2018-02304
• Device Sequence Number: 11340790
• Product Code: PNY
• UDI-Device Identifier: 08717648213120
• UDI-Public: 08717648213120
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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: 08/28/2017
• Device Catalogue Number: 1235350-18
• Device Lot Number: 6082961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 03/29/2018
• 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
• Patient Age: 55 YR
• Patient Weight: 93