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

Catalog Number	1235300-28
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	01/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.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.The reported patient effects of angina and restenosis, 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.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 the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2016, following pre-dilatation with a 2.75mm trek dilatation catheter, a 3.0x28mm absorb bioresorbable vascular scaffold (bvs) was implanted in the mid left anterior descending (lad) coronary artery lesion.Post dilatation was performed using a 3.25x20mm trek catheter.On (b)(6) 2018, restenosis was noted at the bvs site and the patient experienced associated angina, class 3.Another percutaneous procedure was performed as treatment.A non-abbott stent was implanted as treatment at the bvs restenosed site.There was no additional information provided regarding this issue.

• 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: 7232391
• Report Number: 2024168-2018-00721
• Device Sequence Number: 13887382
• Product Code: PNY
• UDI-Device Identifier: 08717648213069
• UDI-Public: 08717648213069
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 01/31/2018

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 Catalogue Number: 1235300-28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/31/2018
• 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: 63 YR