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	Non specific EKG/ECG Changes (1817); Thrombosis (2100)
Date of Event	12/10/2016
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.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 effect of thrombosis, as listed in the absorb gt1 instructions for use (ifu), is a known adverse event 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.
Event or Problem Description
It was reported that the patient presented with a st-elevated myocardial infarction (stemi).The procedure was to treat a de novo lesion located in the proximal left anterior descending (lad) artery.The vessel was determined to be greater than 2.5 mm in diameter.Predilatation was performed with a non-abbott balloon catheter with the residual stenosis reduced to less than 40%.A 3.0 x 23 mm absorb gt1 scaffold was deployed and post-dilatation was performed with a 3.5 x 12 non-abbott balloon catheter at 12 atmospheres (atm).The final angiographic residual stenosis was less than 10%.The absorb gt1 scaffold was not confirmed to be fully apposed to the vessel wall because imaging with intravascular ultrasound or optical coherence tomography was not available in the hospital.Twelve hours after the procedure st elevation was noted and subsequently in-scaffold thrombosis was identified in the absorb gt1 scaffold.The patient was treated with balloon angioplasty.Patient is doing well.It was confirmed that the patient was compliant in following the dual antiplatelet drug therapy (dapt) consisting of clopidogrel after the index procedure.The patients medication was changed from clopidogrel to prasugrel.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: 6216061
• Report Number: 2024168-2016-09405
• Device Sequence Number: 841405
• Product Code: PNY
• UDI-Device Identifier: 08717648213052
• UDI-Public: (01)08717648213052(17)180408(10)6101161
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2016

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: 04/08/2018
• Device Catalogue Number: 1235300-23
• Device Lot Number: 6101161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2016
• Initial Report FDA Received Date: 12/30/2016
• 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: Required Intervention