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

Catalog Number	1235250-28
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	11/02/2016
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.The reported patient effects of thrombosis, as listed in the absorb gt1 instructions for use, is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.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 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 the patient presented with non-st-elevation myocardial infarction (nstemi).The procedure was to treat a lesion in the proximal left anterior descending coronary artery.The lesion was pre-dilated with an unspecified 2.5mm balloon dilatation catheter.The 2.5x28 mm absorb gt1 bioresorbable vascular scaffold (bvs) was deployed without issue.Post-dilatation was performed with 3.0x15 mm and 2.5x20 mm nc balloons.An optical coherence tomography (oct) catheter was advanced in the patient anatomy confirming the scaffold was fully apposed to the vessel wall at which time thrombus was noted in the bvs.The thrombus was treated by increasing medication.The patient is stable.There was no clinically significant delay in the 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: 6106374
• Report Number: 2024168-2016-07998
• Device Sequence Number: 660662
• Product Code: PNY
• UDI-Device Identifier: 08717648212987
• UDI-Public: (01)08717648212987(17)170711(10)6071261
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 11/16/2016

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: 07/11/2017
• Device Catalogue Number: 1235250-28
• Device Lot Number: 6071261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2016
• Initial Report FDA Received Date: 11/16/2016
• 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
• Patient Age: 80 YR
• Patient Weight: 70