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	04/27/2018
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.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 electronic 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, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2017 the 3.5x18 mm absorb gt1 scaffold was implanted in the proximal left anterior descending artery.On (b)(6) 2018 scaffold thrombosis was seen in the absorb gt1 on oct [optical coherence tomography], ivus [intravascular ultrasound], and angiogram.The patient had chest pain with the thrombosis which was diagnosed during a regular hospital visit.A non-abbott stent was implanted to treat the thrombus.The condition resolved the same day.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).A review of the lot history record of the reported lot could not be conducted because the lot number was not provided.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 the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that on (b)(6) 2017 the 3.0x12 mm absorb gt1 scaffold was implanted in the mid left anterior descending (lad) coronary artery; not a 3.5x18 in the proximal lad, as was originally thought.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: 7535030
• Report Number: 2024168-2018-03823
• Device Sequence Number: 13496716
• Product Code: PNY
• UDI-Device Identifier: 08717648213120
• UDI-Public: 08717648213120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2018

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: 10/05/2017
• Device Catalogue Number: 1235300-12
• Device Lot Number: 6100661
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 07/06/2018
• 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: 80 YR
• Patient Weight: 46