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	Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot numbers were not provided.The reported patient effects of myocardial infarction and thrombosis, as listed in the absorb gt1 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.
Event or Problem Description
It was reported the elective procedure on (b)(6) 2016 was following a stress test that revealed a focal calcification in the left descending coronary (lad) artery.The calcified lesion was proximal to mid lad with 75% stenosis.Intravascular ultrasound (ivus) was used to determine vessel size (3.25mm tapering to 3.0mm).Several passes with an atherectomy catheter were made, followed by pre-dilatation with a 2.5 mm nc trek balloon, reducing the stenosis to less than 40%.The 3.0x23 mm absorb gti scaffold was implanted at 8 atmospheres and post-dilated with a 3.0 mm nc trek balloon.Ivus showed proximal under expansion so additional post-dilatation was done with a 3.5 mm nc trek balloon.Ivus showed satisfactory apposition and expansion.Great angiographic results; residual stenosis was less than 10%.On (b)(6) 2016, the patient presented with an st elevated myocardial infarction (stemi).Angiography showed the scaffold was occluded with thrombus.A 3.0x28 mm xience stent was implanted for treatment of the thrombus.The patient is doing well.It was confirmed that the patient had not been compliant with dual antiplatelet therapy (dapt) (had not taken aspirin since the procedure).The physician attributes the thrombus to non-compliance; not to a device issue.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: 6142957
• Report Number: 2024168-2016-08558
• Device Sequence Number: 13569047
• Product Code: PNY
• UDI-Device Identifier: 08717648213052
• UDI-Public: (01)08717648213052
• 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): 12/02/2016

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 Catalogue Number: 1235300-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 12/02/2016
• 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; Disability
• Patient Age: 84 YR
• Patient Weight: 45