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

Catalog Number	1235250-28
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Thrombosis (2100); Diaphoresis (2452)
Date of Event	09/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The incident information was reviewed; however, there was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.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 angina, myocardial infarction and thrombosis, as listed in the absorb gt1 instructions for use is a known adverse event associated with the use of coronary scaffolds in native coronary arteries.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 there is no indication of a product quality issue with respect to manufacture, design or labeling.The other 2 scaffolds referenced are filed under separate medwatch reports.
Event or Problem Description
It was reported that on (b)(6) 2016 , 3 absorb scaffolds were successfully implanted in the left anterior descending (lad) artery, without issue.Subsequently, the same day the patient had chest pain; however, repeat angiography showed no stent thrombosis and the scaffolds were widely patent.The patient was discharged.On (b)(6) 2016, the patient presented with chest pain, diaphoresis and had an st segment elevation myocardial infarction (stemi).The patient was hospitalized and angiography showed thrombosis in the distal scaffolds; however, the proximal most part of the vessel was open.A 38 mm xience alpine stent was used as treatment with a good outcome.There was no reported adverse patient sequela.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: 5973439
• Report Number: 2024168-2016-06323
• Device Sequence Number: 85591
• Product Code: PNY
• UDI-Device Identifier: 08717648212987
• UDI-Public: (01)08717648212987(17)170508(10)6050961
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/23/2016

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: 05/08/2017
• Device Catalogue Number: 1235250-28
• Device Lot Number: 6050961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2016
• Initial Report FDA Received Date: 09/23/2016
• 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 (X2)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 77