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

Catalog Number	1235250-18
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Thrombosis (2100)
Date of Event	11/24/2016
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.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.The reported patient effects of angina and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, 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.
Event or Problem Description
It was reported that the patient presented with segment elevation myocardial infarction (stemi) on (b)(6) 2016.The procedure was to treat a lesion in the mid left circumflex artery with mild tortuosity and chronic total occlusion.A 2.5x15mm non-abbott balloon catheter was inflated to nominal pressure to predilate the lesion.A 2.5x18mm absorb gt1 scaffold delivery system (sds) was implanted without issue.A 2.75x15mm non-abbott balloon catheter was inflated to nominal pressure to post dilate the scaffold.Twenty six hours later and while still in the hospital, the patient experienced chest pressure, st elevations and an increase in troponin.Optical coherence tomography (oct) was used to confirm that the area around the scaffold was cloudy due to thrombosis.A non-compliant balloon catheter was used to successfully treat the thrombosis in the scaffold.The procedure was ended.Following the case the patient was administered a heparin drip for 24 hours in addition to aspirin and effient.The patient was discharged four days later on november 29, 2016.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: 6167892
• Report Number: 2024168-2016-08808
• Device Sequence Number: 1418681
• Product Code: PNY
• UDI-Device Identifier: 08717648212963
• UDI-Public: (01)08717648212963(17)170821(10)6082261
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/12/2016

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: 08/21/2017
• Device Catalogue Number: 1235250-18
• Device Lot Number: 6082261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/12/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR