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

Catalog Number	1235300-23
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.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 myocardial infarction and thrombosis, are listed in the absorb gt1 instructions for use as known adverse events associated with the use of a coronary scaffold in native coronary arteries.It should be noted that the absorb gt1 instructions for use states: an unexpanded scaffold may be retracted into the guiding catheter one time only.An unexpanded scaffold should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the scaffold may be damaged or dislodged during retraction back into the guiding catheter.The reported resistance during advancement and treatment appears to be related to the circumstances of the procedure; however, a conclusive cause for the reported patient effects could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified mid left circumflex artery.In (b)(6) 2017, the patient presented with a non st elevated myocardial infarction (nstemi).The vessel was confirmed with optical coherence tomography (oct) to be greater than 2.5mm.A thrombectomy device was used an pre-dilatation was performed with a 2.5 x 12 mm non-abbott balloon catheter to 16 atmospheres.A 3.0 x 23 mm absorb gt1 scaffold could not cross through the moderate calcium in the lcx.The device was removed and re-inserted through a guideliner and was implanted at 16 atmospheres.Post dilatation was performed with a 3.5 x 15 mm non-abbott nc balloon catheter inflated to 17 and 18 atmospheres and a 3.75 x 12 mm nc balloon catheter to 18 atmospheres.The residual stenosis was 0%.The scaffold was confirmed by oct to be fully apposed to the vessel wall.On 26 april 2017, the patient returned with a nstemi and in-scaffold thrombosis was confirmed with oct.A xience alpine stent was implanted to treat the thrombosis.It is unknown if the patient was compliant with dual antiplatelet therapy.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: 6582185
• Report Number: 2024168-2017-04371
• Device Sequence Number: 16353239
• Product Code: PNY
• UDI-Device Identifier: 08717648213052
• UDI-Public: (01)08717648213052
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1235300-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/22/2017
• 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; Disability
• Patient Age: 70 YR
• Patient Weight: 94