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	Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	08/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The absorb gt1 3.0 x 23 mm scaffold referenced is being filed under a separate manufacturer report number.The device was not returned for evaluation.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 myocardial infarction and thrombosis, as listed in the absorb gt1 bioresorbable vascular scaffold (bvs) system, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.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 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.
Event or Problem Description
It was reported that the procedure on (b)(6) 2016 was to treat a patient due to abnormal stress test.The mid left anterior descending (lad) artery which was heavily calcified and there was difficulty getting a guide wire down.Pre-dilatation was performed with a 2.0 semi-compliant balloon and again with a 3.0 non-compliant (nc) balloon.The 3.0 x 23 mm and 3.0 x 12 mm absorb gt1 scaffolds were implanted overlapping and post-dilated twice with a 3.5 nc trek (16 and 18 atmospheres).Optical coherence tomography (oct) was attempted 3 times, but never got a complete view of the scaffolds distal to proximal.Final angiography showed less than 10% residual stenosis.On (b)(6) 2016, the patient presented to the hospital with an st-elevated myocardial infarction (stemi).Angiography confirmed thrombosis in the scaffolds.Two additional drug eluting stents were implanted for treatment with a good final patient outcome.It was confirmed that the patient was not compliant with the dual anti-platelet therapy (dapt) after the index procedure.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: 5883196
• Report Number: 2024168-2016-05479
• Device Sequence Number: 19125570
• Product Code: PNY
• UDI-Device Identifier: 08717648213021
• UDI-Public: (01)08717648213021(17)160401(10)6051661
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/17/2016

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 Expiration Date: 04/01/2016
• Device Catalogue Number: 1235300-12
• Device Lot Number: 6051661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2016
• Initial Report FDA Received Date: 08/17/2016
• 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 3.0 X 23 MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 69 YR
• Patient Weight: 74